MEDICINES AND ALLIED SUBSTANCES ACT: SUBSIDIARY LEGISLATION
INDEX TO SUBSIDIARY LEGISLATION
Medicines and Allied Substances (Agro-Veterinary Shops) Regulations
Medicines and Allied Substances (Dispensing Certificates) Regulations
Medicines and Allied Substances (Health Shops) Regulations
Medicines and Allied Substances (Fees) Regulations
Medicines and Allied Substances (Importation and Exportation) Regulations
Medicines and Allied Substances (Certificate of Registration) Regulations
Medicines and Allied Substances (Pharmaceutical Licence) Regulations
Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations
Medicines and Allied Substances (Expert Advisory Committee) Regulations
MEDICINES AND ALLIED SUBSTANCES (AGRO-VETERINARY SHOPS) REGULATIONS
[Section 29]
Arrangement of Regulations
Regulation
PART I
PRELIMINARY
PART II
AGRO-VETERINARY SHOP PERMIT
5. Rejection of application for permit
7. Application for renewal of permit
10. Application for duplicate permit
13. Location of agro-veterinary shop
14. Identity of agro-veterinary shop
15. Sale of veterinary medicines
16. Sale, supply and dispensing of veterinary medicines
17. Storage of veterinary medicines
PART III
GENERAL PROVISIONS
18. Register of agro-veterinary shop permits
SI 10 of 2016.
PART I
PRELIMINARY
These Regulations may be cited as the Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016.
In these Regulations, unless the context otherwise requires-
"authorised supplier" means a holder of a pharmaceutical licence issued under section 34 of the Act;
"insanitary conditions" means the conditions or circumstances that could cause contamination of a medicine or allied substance with dirt or filth or could render the medicine or allied substance injurious or dangerous to health;
"permit" means an agro-veterinary shop permit issued under section 29 of the Act; and
"responsible person" means a person who has the control and management of an agro-veterinary shop.
PART II
AGRO-VETERINARY SHOP PERMIT
(1) A person shall apply to the Authority for a permit in Form I set out in the First Schedule.
(2) The Authority shall, within 14 days of the receipt of an application, notify the applicant of the decision of the Authority in respect of the application.
(3) A separate application shall be made and a separate permit issued in respect of each premises.
(4) The Authority may inspect the premises in respect of which an application for a permit is made to determine if the applicant meets the requirements of the Act and the guidelines issued by the Authority.
The Authority may request an applicant to submit information in relation to an application for a permit in Form II set out in the First Schedule.
5. Rejection of application for permit
(1) The Authority shall reject an application for a permit if-
(a) the applicant fails to meet the requirements of the Act and the guidelines issued by the Authority;
(b) the permit issued to the applicant was revoked by the Authority within a period of two years preceding the application; or
(c) the applicant is convicted of an offence under the Act or any other relevant written law.
(2) The Authority shall, where it rejects an application under sub-regulation (1), inform the applicant within seven days of the decision in Form III set out in the First Schedule.
(1) The Authority shall, where the applicant meets the requirements of the Act and the guidelines issued by the Authority, issue a permit in Form IV set out in the First Schedule.
(2) A permit shall be valid for two years from the date of issue.
(3) A permit may be issued in respect of the following classes of agro-veterinary shops-
(a) Class I, to stock for sell the veterinary medicines and allied substances specified in Part A of the Second Schedule;
(b) Class II, to stock for sale the veterinary medicines and allied substances as specified in Part B of the Second Schedule; and
(c) Class III, to stock for sale the veterinary medicines and allied substances specified in Part C of the Second Schedule.
(4) The classes of agro-veterinary shops shall be managed as follows-
(a) Class I, by a registered veterinary surgeon or pharmacist;
(b) Class II, by a registered veterinary para-professional under the supervision of a registered veterinary surgeon or pharmacist; and
(c) Class III, by a suitably qualified person as determined by the Authority.
7. Application for renewal of permit
(1) An application for the renewal of a permit shall be made to the Authority in Form V set out in the First Schedule.
(2) The Authority shall, within 14 days of receipt of an application for the renewal of a permit, grant the application if the applicant meets the requirements of the Act and the guidelines issued by the Authority and has complied with the terms and conditions of the permit.
(3) A permit that is not renewed by the Authority lapses on its date of expiry.
(1) A permit shall be used solely by the holder and is not transferable to any other person without the prior approval of the Authority.
(2) An application for approval to transfer a permit shall be made to the Authority in Form VI set out in the First Schedule.
(3) The Authority shall, within 30 days of receipt of an application for the transfer of a permit, approve the transfer if the applicant meets the requirements of the Act and the guidelines issued by the Authority and issue the transferee with a new permit.
(4) The Authority shall reject an application for the transfer of a permit if the applicant fails to comply with the conditions for the grant of the permit, the provisions of the Act and the guidelines issued by the Authority.
(5) The Authority shall, where it rejects an application to transfer a permit under sub-regulation (4), inform the applicant in Form III set out in the First Schedule.
(1) The Authority may amend a permit where-
(a) some other person succeeds to the interest of the business of the holder;
(b) the name of the business changes; or
(c) there is a change in the employment of the responsible person.
(2) An application for the amendment of a permit shall be made in Form VII set out in the First Schedule.
(3) The Authority shall communicate its decision to the permit holder within 14 days of receipt of the application for amendment of the permit.
(4) The Authority shall, where it approves the amendment of a permit, issue the applicant with a new permit.
10. Application for duplicate permit
A person may, where a permit is lost, damaged or defaced, apply to the Authority for a duplicate permit in Form VIII set out in the First Schedule.
(1) The Authority shall suspend a permit if-
(a)the holder operates the agro-veterinary shop in respect of which it is issued under insanitary conditions;
(b) the holder or manager of the agro-veterinary shop in respect of which it is issued obtains or sells veterinary medicines from unauthorised suppliers or stocks and sells unauthorised products;
(c) the agro-veterinary shop in respect of which it was issued contravenes the prescribed standards or the provisions of the Act;
(d) the agro-veterinary shop is not managed or controlled by a responsible person determined by the Authority;
(e) the responsible person fails to maintain the required records on veterinary medicines and allied substances;
(f) the agro-veterinary shop stocks and sells medicines that are not on the prescribed list; or
(g) the holder contravenes the terms and conditions of the permit, the provisions of the Act or any other relevant written law.
(2) The Authority shall, before suspending a permit, give notice to the holder of the intention to suspend the permit and request the holder to show cause, within a specified period, why the permit should not be suspended.
(3) A notice of intention to suspend a permit shall be in Form IX set out in the First Schedule.
(4) The Authority shall suspend a permit if the holder of the permit fails to take remedial measures within the period specified in the notice issued under sub-regulation (2).
(5) A notice of the suspension of a permit shall be in Form X set out in the First Schedule.
(6) The Authority shall, during the period of the suspension of the permit, quarantine any product affected by the suspension of the permit at the cost of the permit holder.
(1) The Authority shall revoke a permit if the holder-
(a) contravenes the provisions of the Act or any other relevant written law or breaches the terms or conditions of the permit;
(b) fails to take corrective measures following the suspension of the permit within the specified period;
(c) changes the agro-veterinary shop premises without authorisation; or
(d) obtained the permit by fraud or deliberate or negligent submission of false information or statements.
(2) The Authority shall, before revoking a permit, give notice to the holder of the permit of the intention to revoke the permit and request the holder to show cause, within a specified period, why the permit should not be revoked.
(3) A notice of the intention to revoke a permit shall be in Form IX set out in the First Schedule.
(4) The Authority shall revoke a permit if the holder fails to take remedial measures during the period specified by the Authority.
(5) A notice of the revocation of a permit shall be in Form X set out in the First Schedule.
(6) Upon the revocation of a permit, the medicines and allied substances on the premises shall be quarantined and disposed of as directed by the Authority at the holder's cost.
13. Location of agro-veterinary shop
The Authority shall, in considering an application for a permit, give priority to submissions filed by the applicants in the following areas-
(a) rural areas and districts where access to medicines is limited; and
(b) peripheral areas of municipalities or cities, where access to medicines is limited.
14. Identity of agro-veterinary shop
An agro-veterinary shop shall fix a standard logo for purposes of identifying the agro-veterinary shop as specified in the guidelines issued by the Authority.
15. Sale of veterinary medicines
A holder of a permit shall sell the veterinary medicines prescribed in the Second Schedule.
16. Sale, supply and dispensing of veterinary medicines
Veterinary medicines shall be sold, supplied and dispensed in accordance with the guidelines issued by the Authority.
17. Storage of veterinary medicines
(1) The storage of veterinary medicines in an agro-veterinary shop shall be in the manufacturer's original container and under conditions stipulated by the manufacturer.
(2) Where veterinary medicines are transferred to another container, care shall be taken to protect the integrity of the product and prevent contamination of the medicines.
(3) The Authority shall, where it is established that the holder of a permit stocks veterinary medicines or products under insanitary conditions, direct the holder to dispose of the veterinary medicines or products at the holder's cost.
PART III
GENERAL PROVISIONS
18. Register of agro-veterinary shop permits
(1) The Authority shall keep and maintain a register of agro-veterinary permits in Form XI set out in the First Schedule.
(2) The register referred to in sub-regulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times and upon payment of an inspection fee prescribed in the Third Schedule.
[Regulations 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12]
PRESCRIBED FORMS
Form I
[Regulation 3(1)]
(To be completed in triplicate)
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Form II
[Regulation 4]
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) |
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The Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016 |
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REQUEST FOR INFORMATION |
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To: ................................................................................................................................ |
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Address: ....................................................................................................................... |
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Application No.: ............................................................................................................. |
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You are requested to furnish the following information or documents in respect of your application for ................................................................................................................ |
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(a) ............................................................................................................................ |
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(b) ............................................................................................................................ |
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(c) ............................................................................................................................ |
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(d) ............................................................................................................................ |
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within ..................... days of this notice. |
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If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and shall be rejected. |
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Dated this ............ day of ......................... 20...... |
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.................................................. |
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Form III
[Regulations 5(2) and 8(5)]
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF REJECTION OF APPLICATION |
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(1) Here insert the full names and address of the applicant |
To (1) ................................................................................................. |
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................................................................................................. |
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(2) Here insert the reference No. of the application |
IN THE MATTER OF (2) ........................................ you are notified that your application for (3) .................................................... has been rejected by the Authority on the following grounds: |
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(3) Here insert type of application |
(a) ....................................................................................... |
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(b) .......................................................................................... |
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(c) ............................................................................................ |
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(d) ........................................................................................... |
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Dated this .......... day of ........................, 20...... |
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................................................. |
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Form IV
[Regulation 6]
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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AGRO-VETERINARY SHOP PERMIT |
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Registration No.: .................................................. AVS |
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Permit No.: AVS/........................................................ |
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This is to certify that (Name of agro-veterinary shop) ..................................................... |
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..................................................................................................................................... |
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of (Physical address) .................................................................................................... |
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.................................................................................................................................... |
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................................................................... is registered to operate an agro-veterinary shop. |
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Name of responsible person: ........................................................................................... |
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The conditions of the agro-veterinary shop permit are overleaf. |
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This permit is valid until ......................... 20..... |
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.................................................. |
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Conditions for agro-veterinary shop permit |
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1. Any change in the responsible person, name, location or condition of permit of the agro-veterinary shop shall be approved by the Authority. |
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2. The agro-veterinary shop shall only stock and sell medicinal products that are on the prescribed list. |
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3. The premises and the manner in which the business is to be conducted must comply with the requirements of the Medicines and Allied Substances Act, No. 3 of 2013, and any other relevant written law. |
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4. The agro-veterinary shop permit is not transferable without the written approval of the Authority. |
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5. The agro-veterinary shop permit shall, upon grant, be displayed conspicuously at the front shop in a place visible to the public. |
Form V
[Regulation 7(1)]
(To be completed in triplicate)
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Form VI
[Regulation 8(2)]
(To be completed in triplicate)
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Form VII
[Regulation 9]
(To be completed in triplicate)
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Form VIII
[Regulation 10]
(To be completed in triplicate)
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Form IX
[Regulations 11(3) and 12(3)]
(To be completed in triplicate)
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF INTENTION TO SUSPEND/REVOKE AGRO-VETERINARY SHOP PERMIT |
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(1) Here insert the full names and address of holder of permit |
To (1) ............................................................................................ |
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...................................................................................................... |
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..................................................................................................... |
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(2) Here insert the Permit No. |
IN THE MATTER OF (2) ....................... .... you are notified that the Authority intends to *suspend/revoke your permit on the following grounds: |
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(a) ............................................................................................... |
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(b) ............................................................................................... |
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(c) ............................................................................................... |
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(d) ............................................................................................... |
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(3) Here insert the number of days stipulated |
Accordingly, you are requested to show cause why your permit should not be *suspended/revoked and to take action to remedy the breaches set out in paragraphs ......................... (above) within (3) ............ days of receiving this notice. Failure to remedy the said breaches shall result in the *suspension/revocation of your permit. |
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Dated this ............. day of ......................... 20..... |
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(4) Signature of Director-General |
(4) ................................................ |
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Form X
[Regulations 11(5) and 12(5)]
(To be completed in triplicate)
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF SUSPENSION OR REVOCATION OF AGRO-VETERINARY SHOP PERMIT |
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(1) Here insert the full names and address of holder of permit |
To (1) ................................................................................ |
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.......................................................................................... |
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(2) Here insert the permit no. |
IN THE MATTER OF (2) ................................................. you are notified that your permit has been *suspended for a period of (3) .................... /*revoked on the following grounds: |
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(3) Here insert the period |
(a) ................................................................................ |
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(4) Signature of Director-General |
(b) ............................................................................... |
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(c) .............................................................................. |
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(d) .............................................................................. |
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Dated this ............. day of ......................... 20..... |
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(4) ................................................ |
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Form XI
[Regulation 18]
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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REGISTER OF AGRO-VETERINARY SHOP PERMITS |
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No. |
Name and address of business |
Permit No. |
Class of permit |
Registration number |
Date of issue |
Expiry date |
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1. |
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2. |
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3. |
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4. |
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5. |
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6. |
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7. |
[Regulations 16(3) and 15(1)]
VETERINARY PRODUCTS FOR AGRO-VETERINARY SHOPS
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A. Agro-Veterinary Shop Class I |
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1. All prescription-only veterinary medicine (POM-V) with marketing authorisation |
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2. All pharmacy (P-V) veterinary medicines with market authorisation |
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3. All general sales (GS-V) veterinary medicines and allied substances |
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4. All medicines that have been imported with special authorisation |
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5. Medicines and allied substances added by guidelines issued by the Authority on the recommendation of the Ministry responsible for veterinary services in response to changing disease epidemiological status or disease outbreaks |
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B. Agro-Veterinary Shops Class II |
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Part A |
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No. |
Item |
Dosage Form |
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Analgesics- non-steroidal anti-inflammatories |
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1 |
Acetaminophen |
Tablets or powder |
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2 |
Carprofen |
Tablets |
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3 |
Diclofenac |
Tablets or gel |
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4 |
Dimethyl sulfoxide (DMSO) |
Tablets, or cream or ointment |
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5 |
Dipyrone |
Injection |
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6 |
Flunixin meglumine |
Injection |
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7 |
Ketoprofen |
Tablets or powder |
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8 |
Meloxicam |
Tablets or powder |
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Antiprotozoa |
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1 |
Amprolium |
Injectable solutions |
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2 |
Amprolium |
Soluble powders |
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3 |
Parvaquone |
Injectable solutions |
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4 |
Burparvaquone |
Injectable solutions |
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5 |
Diminazene aceturate |
Injectable solutions |
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6 |
Diminazene aceturate |
Injectable solutions granules |
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7 |
Imidocarb dipropionate |
Injectable solutions |
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8 |
Isometamidium chloride |
Injectable solutions |
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9 |
Parvarquone |
Injectable solutions powder |
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10 |
Quinapyramine sulphate/chloride |
Injectable solutions |
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Antifungals |
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1 |
Fluconazole |
Tablets or powder |
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2 |
Griseofulvin |
Tablets or capsules |
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3 |
Ketoconazole |
Tablets, capsules, lotions, shampoo |
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Antihistamines |
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1 |
Chlorpheniramine |
Tablets |
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2 |
Cimetidine |
Tablets |
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3 |
Diphenhydramine |
Tablets |
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4 |
Cetirizine |
Tablets |
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Antimicrobials |
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1 |
Amikacin |
Tablets |
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2 |
Amoxicillin |
Tablets, capsules or injection |
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3 |
Ampicillin |
Tablets, capsules or injection |
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4 |
Doxycycline |
Tablets, capsules or injection |
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5 |
Neomycin |
Pessaries, ointment or creams |
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6 |
Oxytetracycline injectable solutions |
All concentrations and dosage forms |
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7 |
Oxytetracycline soluble powder |
All concentrations and dosage forms |
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8 |
Oxytetracycline soluble powder with vitamins |
All concentrations and dosage forms |
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9 |
Penicillin |
Injection |
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10 |
Penicillin-streptomycin |
Injection |
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11 |
Sulfadimidine |
Injectable solutions 33% w/v, 33.3% |
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12 |
Sulfadimidine |
Powder |
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13 |
Tetracycline |
Ointment or spray |
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14 |
Tetracycline |
Powder |
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15 |
Tiamulin |
Powder |
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Autonomic drugs |
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1 |
Atropine |
Injection |
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2 |
Bethanechol |
Injection |
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3 |
Glycopyrrolate |
Injection |
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Electrolytes/Nutritional |
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1 |
Calcium |
Injection and powder |
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2 |
Iron |
Injection or oral liquid |
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3 |
Methionine, D-L |
Powder |
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4 |
Multivitamin |
Injectable solution |
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5 |
Multivitamin |
Soluble powder |
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6 |
Potassium |
Injection |
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7 |
Selenium/Vitamin E |
Injection |
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8 |
Taurine |
Injection |
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9 |
Vitamin A & D |
Injection |
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10 |
Vitamin B complex |
Injection |
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11 |
Vitamin C |
Tablets or powder |
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12 |
Vitamin D |
Injection |
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13 |
Vitamin K |
Injection |
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14 |
Sodium chloride 0.9% (N-Saline) |
Solution |
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15 |
Dextrose 5%, 10%, 50% |
Solution |
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16 |
Ringers lactate |
Solution |
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Gastrointestinal agents |
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1 |
Metoclopramide |
Tablets |
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2 |
Sucralfate |
Tablets |
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Hormones |
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1 |
Dexamethasone |
Injection |
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2 |
Dinoprost |
Injection |
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3 |
Estradiol cypionate |
Injection |
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4 |
Gonadorelin |
Injection |
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5 |
Oxytocin |
Injection |
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6 |
Progesterone |
Injection |
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7 |
Stilboestral dipropionate |
Injection |
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8 |
Triamcinolone |
Injection |
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Respiratory |
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1 |
Aminophyline |
Tablet or injection |
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2 |
Dextromethorphan |
Injection |
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3 |
Doxapram |
Injection |
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Sedatives |
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1 |
Acepromazine |
Tablet |
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Miscellaneous |
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1 |
Methimazole |
Tablet |
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2 |
Propylene glycol |
Liquid |
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3 |
Protamine sulfate |
Powder |
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Allied substances (Acaricides) |
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1 |
Chlorfenvinphos |
Concentrate |
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2 |
Dichlorvos |
Concentrate |
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Anthelmintics |
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1 |
Albendazole |
Bolus up to 2.5 g |
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2 |
Albendazole |
Suspensions 2.5% w/v,10% w/v |
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3 |
Clorsulon |
Injection |
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4 |
Closantel |
Injection or drench |
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5 |
Febantel |
Drench, bolus or injection |
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6 |
Fenbendazole |
Drench, bolus or injection |
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7 |
Haloxon |
Drench |
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8 |
Hexachloroethane |
Drench |
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9 |
Hexachloroparaxylene |
Drench |
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10 |
Hexachlorophene |
Drench |
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11 |
Ivermectin |
Bolus or powder |
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12 |
Ivermectin |
Injectable solutions |
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13 |
Levamisole |
Bolus or powder |
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14 |
Levamisole hydrochloride |
Drench, powder or injection |
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15 |
Levamisole phosphate injection |
Injection |
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16 |
Mebendazole |
Drench, tablets, bolus |
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17 |
Niclosamide |
Drench or bolus |
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18 |
Nitoxynil |
Drench or bolus |
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19 |
Oxfendazole |
Drench or bolus |
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20 |
Oxibendazole |
Drench or bolus |
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21 |
Oxyclozanide |
Drench or bolus |
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22 |
Oxyclozanide |
Drench or bolus |
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23 |
Parbendazole |
Drench or bolus |
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24 |
Piperazine citrate |
Soluble powders |
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25 |
Piperazine citrate |
Tablets |
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26 |
Praziquantel |
Tablets |
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27 |
Pyrantel |
Tablets or oral liquid |
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28 |
Rafoxanide |
Drench or bolus |
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29 |
Tetramisole |
Drench or bolus |
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30 |
Thiabendazole |
Drench or bolus |
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31 |
Thiophanate |
Drench or bolus |
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32 |
Trichlorfon |
Drench or bolus |
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33 |
Triclabendazole |
Drench or bolus |
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34 |
Ivermectin/clorsulon |
Injection |
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35 |
Levamisole/oxyclozanide |
Drench or bolus |
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36 |
Piperazine citrate/pyrantel parmoate |
Tablets or oral liquid |
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37 |
Levamisole/piperazine dihydrochloride |
Powder |
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Biologicals: |
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Poultry vaccines |
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1 |
Anticoccidial vaccines |
All dosage forms |
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2 |
Chicken anaemia virus vaccines |
All dosage forms |
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3 |
Fowl cholera vaccines |
All dosage forms |
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4 |
Fowl pox vaccines |
All dosage forms |
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5 |
Fowl typhoid vaccines |
All dosage forms |
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6 |
Infectious bronchitis vaccines |
All dosage forms |
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7 |
Infectious bronchitis/newcastle disease/egg drop syndrome baccines |
All dosage forms |
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8 |
Infectious bronchitis/newcastle inactivated vaccines |
All dosage forms |
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9 |
Infectious bursal disease vaccines |
All dosage forms |
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10 |
Infectious coryza vaccines |
All dosage forms |
|
11 |
Infectious laryngotracheitis vaccines |
All dosage forms |
|
12 |
Newcastle cloned vaccines |
All dosage forms |
|
13 |
Newcastle disease live vaccine |
All dosage forms |
|
14 |
Newcastle disease inactivated vaccines |
All dosage forms |
|
15 |
Newcastle disease thermostable vaccines |
All dosage forms |
|
16 |
Salmonella vaccines for avians |
All dosage forms |
|
17 |
Egg drop syndrome vaccines |
All dosage forms |
|
Ruminant vaccines |
||
|
1 |
Anaplasmosis vaccines |
All dosage forms |
|
2 |
Anthrax vaccines |
All dosage forms |
|
3 |
Avian & bovine tuberculin kit |
Injectible |
|
4 |
Black leg-clostridium chauvoei vaccines |
All dosage forms |
|
5 |
Blackleg/anthrax vaccines |
All dosage forms |
|
6 |
Blue tongue vaccines |
All dosage forms |
|
7 |
Botulism vaccines |
All dosage forms |
|
8 |
Botulism/anthrax vaccines |
All dosage forms |
|
9 |
Anthrax/black quarter/botulism vaccines |
All dosage forms |
|
10 |
Bovine ephemeral fever vaccines |
All dosage forms |
|
11 |
Brucella vaccines |
All dosage forms |
|
12 |
Calf paratyphoid live and killed vaccines |
All dosage forms |
|
13 |
Enzootic abortion vaccines |
All dosage forms |
|
14 |
Clostridial/pasteurella vaccines |
All dosage forms |
|
15 |
Infectious bovine rhinotracheitis/parainfluenza/bovine respiratory syncitial virus/bovine viral diarrhoea (combination) vaccines, both live and killed |
All dosage forms |
|
16 |
Leptospirosis vaccines |
All dosage forms |
|
17 |
Lumpy skin disease vaccines |
All dosage forms |
|
18 |
Milk ring test antigen |
All dosage forms |
|
19 |
Multiclostridials vaccines |
All dosage forms |
|
20 |
Pasturella vaccines |
All dosage forms |
|
21 |
Pulpy kidney vaccines |
All dosage forms |
|
22 |
Rift valley fever vaccines, live and inactivated |
All dosage forms |
|
23 |
Rota/corona/E.coli vaccine for cattle |
All dosage forms |
|
24 |
Rift valley fever inactivated vaccine for cattle |
All dosage forms |
|
25 |
Rift valley fever live vaccine for sheep |
All dosage forms |
|
26 |
Bovine rota/coronavirus vaccine/clostridium perfringens type C/escherichia coli bacterin/toxoid Injectable vaccine/toxoid |
All dosage forms |
|
27 |
Sheep multiclostridial vaccines |
All dosage forms |
|
28 |
Tetanus vaccines |
All dosage forms |
|
29 |
Tetanus toxoid |
All dosage forms |
|
30 |
Bovine ephemeral fever vaccines |
All dosage forms |
|
31 |
Vibriosis vaccines |
All dosage forms |
|
Pig vaccines |
||
|
1 |
Parvovirus killed vaccine/erysipelothrix/leptospira bacterin vaccine/toxoid |
All dosage forms |
|
2 |
Boar-taint vaccines |
All dosage forms |
|
3 |
E. coli/clostridium perfringens type C beta toxoid |
All dosage forms |
|
Vaccines for companion animals |
||
|
1 |
Equine influenza virus vaccines |
All dosage forms |
|
2 |
Feline viral rhinotracheitis/feline calicivirus/feline panleukopenia vaccines |
All dosage forms |
|
3 |
Canine parvovirus vaccines |
All dosage forms |
|
4 |
Horse sickness polyvalent vaccine |
All dosage forms |
|
5 |
Canine distemper/adenovirus type 2/ parainfluenza/parvovirus modified live virus vaccine/ leptospira bacterin vaccine/toxoid |
All dosage forms |
|
6 |
Rabies vaccines |
All dosage forms |
|
Intra-Uterine infusion drugs |
||
|
1 |
Intrauterine pessaries |
Pessaries |
|
Intramammary infusion drugs |
||
|
1 |
Mastitis intramammary infusion |
Ointments |
|
Ophthalmologic drug |
||
|
1 |
Cloxacillin eye ointment 16.7% w/w |
Ointments |
|
2 |
Dexamethasone ointment or drops |
Ointments or drops |
|
3 |
Doxycycline |
Eye powder |
|
4 |
Neomycin |
Ointment or drops |
|
5 |
Oxytetracycline |
Powder or ointment |
|
Antiseptics |
||
|
1 |
Povidone iodine |
Concentrate |
|
Part B |
||
|
1. All general sales (GSV) veterinary medicines and allied substances |
||
|
2. Medicines and allied substances added by guidelines issued by the Authority on the recommendation of the Ministry responsible for veterinary services in response to changing disease epidemiological status or disease outbreaks |
||
|
Agro-Veterinary Shop Class III |
||
|
Part A |
|
No. |
Item |
Dosage Form |
|
Analgesics-non-steroidal anti-inflammatories |
||
|
1 |
Diclofenac |
Tablets or gel |
|
2 |
Dipyrone |
Injection |
|
Antiprotozoa |
||
|
1 |
Amprolium |
Soluble powders |
|
Diminazene aceturate |
Injectable solutions |
|
|
Antihistamines |
||
|
1 |
Chlorpheniramine |
Tablets |
|
Antimicrobials |
||
|
1 |
Oxytetracycline injectable solutions |
All concentrations and dosage forms |
|
2 |
Oxytetracycline soluble powder |
All concentrations and dosage forms |
|
3 |
Oxytetracycline soluble powder with vitamins |
All concentrations and dosage forms |
|
4 |
Tetracycline |
Ointment or spray |
|
5 |
Tetracycline |
Powder |
|
Electrolytes/Nutritional |
||
|
1 |
Multivitamin |
Soluble powder |
|
2 |
Potassium |
Injection |
|
3 |
Vitamin C |
Tablets or powder |
|
Allied substances (Acaricides) |
||
|
1 |
Chlorfenvinphos |
Concentrate |
|
Anthelmintics |
||
|
1 |
Albendazole |
Bolus up to 2.5 g |
|
2 |
Albendazole |
Suspensions 2.5% w/v,10% w/v |
|
3 |
Closantel |
Injection or drench |
|
4 |
Ivermectin |
Bolus or powder |
|
5 |
Levamisole |
Bolus or powder |
|
6 |
Oxfendazole |
Drench or bolus |
|
7 |
Oxyclozanide |
Drench or bolus |
|
8 |
Parbendazole |
Drench or bolus |
|
9 |
Piperazine citrate |
Soluble powders |
|
10 |
Piperazine citrate |
Tablets |
|
11 |
Praziquantel |
Tablets |
|
12 |
Pyrantel |
Tablets or oral liquid |
|
Biologicals: |
|
|
|
Poultry vaccines |
||
|
1 |
Newcastle disease |
Thermostable vaccines |
|
Ophthalmologic drug |
||
|
1 |
Cloxacillin eye ointment 16.7% w/w |
Ointments |
|
2 |
Doxycycline |
Eye powder |
|
3 |
Neomycin |
Ointment or drops |
|
4 |
Oxytetracycline |
Power or ointment |
|
|
||
|
Part B |
||
|
1. All general sales (GSV) veterinary medicines and allied substances |
||
|
2. Medicines and allied substances added by guidelines issued by the Authority, and are categorised for distribution in Class 3 agro-veterinary shops, on the recommendation of the Ministry responsible for veterinary services in response to changing disease epidemiological status or disease outbreaks |
||
|
Note: All medicines with marketing authorisation for use in humans, if prescribed for use in animals, shall only be accessed from registered pharmacies on prescription from a registered veterinary surgeon. |
MEDICINES AND ALLIED SUBSTANCES (DISPENSING CERTIFICATES) REGULATIONS
[Section 28]
Arrangement of Regulations
Regulation
PART I
PRELIMINARY
PART II
DISPENSING CERTIFICATE
3. Application for certificate
5. Rejection of application for certificate
7. Application for renewal of certificate
10. Application for duplicate certificate
PART III
GENERAL PROVISIONS
15. Register of dispensing certificates
SI 11 of 2016.
PART I
PRELIMINARY
These Regulations may be cited as the Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016.
In these Regulations, unless the context otherwise requires-
"authorised supplier" means a holder of a pharmaceutical licence issued under section 34 of the Act; and
"certificate" means the dispensing certificate issued under section 28 of the Act.
PART II
DISPENSING CERTIFICATE
3. Application for certificate
(1) A person shall apply to the Authority for a certificate in Form I set out in the Schedule.
(2) The Authority shall, within 14 days of the receipt of an application, notify the applicant of the decision of the Authority in respect of the application.
(3) A separate application shall be made and a separate certificate issued in respect of each health facility.
(4) The Authority may inspect the health facility in respect of which an application for a certificate is made to determine if the applicant meets the requirements of the Act and the guidelines issued by the Authority.
(5) The Authority shall consider the following matters in determining an application for a certificate-
(a) the number of health facilities in the area;
(b) the classification of the health facility; and
(c) the competence of the health practitioners responsible for dispensing the medicines.
The Authority may request an applicant to submit information in relation to an application for a certificate in Form II set out in the Schedule.
5. Rejection of application for certificate
(1) The Authority shall reject an application for a certificate if-
(a) the applicant fails to meet the requirements of the Act and the guidelines issued by the Authority;
(b) the certificate issued to the applicant was revoked by the Authority within the preceding two years before the date of the application;
(c) the applicant's practising certificate is withdrawn by the relevant professional body; or
(d) the applicant is convicted of an offence under the Act or any other relevant written law.
(2) The Authority shall, where it rejects an application under sub-regulation (1), inform the applicant within seven days of the decision in Form III set out in the Schedule.
(1) The Authority shall, where the applicant meets the requirements of the Act and the guidelines issued by the Authority, issue a certificate in Form IV set out in the Schedule.
(2) A certificate shall be valid for two years from the date of issue.
7. Application for renewal of certificate
(1) An application for the renewal of a certificate shall be made to the Authority in Form V set out in the Schedule.
(2) The Authority shall, within 14 days of the application for a certificate, renew the certificate if the applicant meets the requirements of the Act and the guidelines issued by the Authority and has complied with the terms and conditions of the certificate.
(3) A certificate that is not renewed by the Authority lapses on its date of expiry.
A certificate shall be used solely by the holder and is not transferable to any other person.
(1) The Authority may amend a certificate where the name of the business changes.
(2) An application for the amendment of a certificate shall be made in Form VI set out in the Schedule.
(3) The Authority shall, where it approves an application for the amendment of a certificate, issue the applicant with a new certificate.
10. Application for duplicate certificate
A person may, where a certificate is lost, damaged or defaced, apply to the Authority for a duplicate certificate in Form VII set out in the Schedule.
(1) The Authority shall suspend a certificate if-
(a)the holder dispenses medicine under insanitary conditions;
(b) the holder or manager of the health facility in respect of which it is issued obtains or sells medicines from unauthorised suppliers or stocks and sells unauthorised products;
(c) the health facility does not comply with good dispensing practices determined by the Authority;
(d) the holder fails to maintain the required records on medicines and allied substances; or
(e) the holder contravenes the terms and conditions of the certificate or the provisions of the Act or any other relevant written law.
(2) The Authority shall, before suspending a certificate, give notice to the holder of the intention to suspend the certificate and request the holder to show cause, within a specified period, why the certificate should not be suspended.
(3) A notice of intention to suspend a certificate shall be in Form VIII set out in the Schedule.
(4) The Authority shall suspend a certificate if the holder of the certificate fails to take remedial measures within the period specified in the notice issued under sub-regulation (3).
(5) A notice of the suspension of a certificate shall be in Form IX set out in the Schedule.
(6) During the period of the suspension of the certificate-
(a) the product affected by the suspension of the certificate shall be quarantined and disposed of at the cost of the certificate holder; and
(b) the health facility to which it relates shall not dispense medicines, except for emergency cases.
(7) The Authority shall lift the suspension of a certificate where the holder complies with the terms and conditions of the suspension.
(1) The Authority shall revoke a certificate if the holder-
(a) contravenes the provisions of the Act or breaches the terms or conditions of the certificate;
(b) fails to take corrective measures following the suspension of the certificate within the specified period;
(c) obtained the certificate by fraud or deliberate or negligent submission of false information or statements; or
(d) fails to comply with any other relevant written law.
(2) The Authority shall, before revoking a certificate, give notice to the holder of the certificate of the intention to revoke the certificate and request the holder to show cause, within a specified period, why the certificate should not be revoked.
(3) A notice of the intention to revoke a certificate shall be in Form VIII set out in the First Schedule.
(4) The Authority shall revoke a certificate if the holder fails to take remedial measures during the period specified by the Authority.
(5) A notice of the revocation of a certificate shall be in Form IX set out in the Schedule.
(6) Upon the revocation of a certificate, the products in the health facility shall be quarantined or disposed of as directed by the Authority at the holder's cost.
(1) Medicines in a health facility shall be dispensed in accordance with the guidelines issued by the Authority.
(2) A holder of a dispensing certificate who undertakes dispensing activities shall stock medicines of the required quality, safety and efficacy.
(3) A patient may request a medical practitioner for a written prescription to enable the patient obtain medicines from any other health facility of their choice.
(1) The storage of medicines in a health facility shall be in the manufacturer's original container and under conditions stipulated by the manufacturer.
(2) The Authority shall, where it determines that the holder of a certificate stocks medicines or products under insanitary conditions, direct the holder to dispose of the medicines or products at the holder's cost.
(3) Where medicines are transferred to another container, care shall be taken to protect the integrity of the product and prevent contamination of the medicines.
PART III
GENERAL PROVISIONS
15. Register of dispensing certificates
(1) The Authority shall keep and maintain a register of dispensing certificates in Form X set out in the Schedule.
(2) The register referred to in sub-regulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times and upon payment of a prescribed inspection fee.
[Regulations 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 15]
PRESCRIBED FORMS
Form I
[Regulation 3(1)]
(To be completed in triplicate)
|
|
Form II
[Regulation 4]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
|
REQUEST FOR INFORMATION |
|
To: ...................................................................................................................... |
|
Address: .............................................................................................................. |
|
Application No.: .................................................................................................... |
|
You are requested to furnish the following information in respect of your application for ................................................ within ..................................... days of this Notice: |
|
(a) .................................................................................................................. |
|
(b) .................................................................................................................. |
|
(c) .................................................................................................................. |
|
(d) .................................................................................................................. |
|
If you fail to furnish the requested information within the stipulated period, your application |
|
Dated this ............. day of ............................. 20.... |
|
................................... |
|
|
Form III
[Regulation 5(2)]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
|
The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
|
|
NOTICE OF REJECTION OF APPLICATION |
|
|
(1) Here insert the full names and address of the applicant |
To (1) ............................................................................................................ |
|
..................................................................................................................... |
|
|
(2) Here insert the reference No. of the application |
IN THE MATTER OF (2) ................................................. you are notified that your application for (3) .............................................................. has been rejected by the Authority on the following grounds: |
|
(3) Here insert type of application |
(a) ............................................................................................................ |
|
(b) ............................................................................................................ |
|
|
(c) ............................................................................................................ |
|
|
(d) ............................................................................................................ |
|
|
Dated this ............. day of .............................., 20..... |
|
|
................................... |
|
|
|
Form IV
[Regulation 6]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
|
DISPENSING CERTIFICATE |
|
Registration No.: ..................................... DC |
|
Certificate No.: DC/................................... |
|
This is to certify that ......................................................................................................... |
|
....................................................................................................................................... |
|
of (Physical address) ....................................................................................................... |
|
....................................................................................................................................... |
|
.............................................................................................. may dispense medicines at |
|
....................................................................................................................................... |
|
Name of Health Facility: ................................................................................................... |
|
This Certificate is valid until ................................... 20.... |
|
The conditions of the Dispensing Certificate are overleaf. |
|
..................................... |
|
|
|
Conditions for Dispensing Certificate |
|
1. The holder shall inform the Authority of any change in the details of the Dispensing Certificate. |
|
2. The premises and the manner in which the business is to be conducted must comply with the requirements of the Medicines and Allied Substances Act, No. 3 of 2013, and any other relevant written law. |
|
3. The Dispensing Certificate is not transferable to any other person. |
|
4. The Dispensing Certificate shall, upon grant, be displayed conspicuously at the health facility in a place visible to the public. |
Form V
[Regulation 7(1)]
(To be completed in triplicate)
|
|
Form VI
[Regulation 9(2)]
(To be completed in triplicate)
|
|
Form VII
[Regulation 10]
(To be completed in triplicate)
|
|
Form VIII
[Regulations 11(3) and 12(3)]
|
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
|
The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
|
|
NOTICE OF INTENTION TO SUSPEND/REVOKE DISPENSING CERTIFICATE |
|
|
(1) Here insert the full names and address of holder of certificate |
To (1) ................................................................................................... |
|
............................................................................................................ |
|
|
............................................................................................................ |
|
|
(2) Here insert the Certificate No. |
IN THE MATTER OF (2) ...................................................... you are notified that the Authority intends to *suspend/revoke your certificate on the following grounds: |
|
|
(a) ................................................................................................ |
|
|
(b) ................................................................................................ |
|
|
(c) ................................................................................................ |
|
|
(d) ................................................................................................ |
|
(3) Here insert the number of days stipulated |
Accordingly, you are requested to show cause why your certificate should not be suspended/revoked and to take action to remedy the breaches set out in paragraphs ................................... (above) within (3) .................... days of receiving this notice. Failure to remedy the specified breaches shall result in the *suspension/revocation of your certificate. |
|
Dated this ............... day of ................................... 20...... |
|
|
................................... |
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|
|
Form IX
[Regulations 11(5) and 12(5)]
|
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
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NOTICE OF SUSPENSION/REVOCATION OF DISPENSING CERTIFICATE |
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(1) Here insert the full names and address of holder of certificate |
To (1) ................................................................................................................. |
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(3) Here insert the Certificate No. |
IN THE MATTER OF (3) ..................................................... you are notified that your certificate has been |
(4) Here insert the period |
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MEDICINES AND ALLIED SUBSTANCES ACT: SUBSIDIARY LEGISLATION
INDEX TO SUBSIDIARY LEGISLATION Medicines and Allied Substances (Agro-Veterinary Shops) Regulations Medicines and Allied Substances (Dispensing Certificates) Regulations Medicines and Allied Substances (Health Shops) Regulations Medicines and Allied Substances (Fees) Regulations Medicines and Allied Substances (Importation and Exportation) Regulations Medicines and Allied Substances (Certificate of Registration) Regulations Medicines and Allied Substances (Pharmaceutical Licence) Regulations Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations Medicines and Allied Substances (Expert Advisory Committee) Regulations
MEDICINES AND ALLIED SUBSTANCES (AGRO-VETERINARY SHOPS) REGULATIONS [Section 29] Arrangement of Regulations Regulation PART I PART II 5. Rejection of application for permit 7. Application for renewal of permit 10. Application for duplicate permit 13. Location of agro-veterinary shop 14. Identity of agro-veterinary shop 15. Sale of veterinary medicines 16. Sale, supply and dispensing of veterinary medicines 17. Storage of veterinary medicines PART III 18. Register of agro-veterinary shop permits SI 10 of 2016.
PART I These Regulations may be cited as the Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016. In these Regulations, unless the context otherwise requires- "authorised supplier" means a holder of a pharmaceutical licence issued under section 34 of the Act; "insanitary conditions" means the conditions or circumstances that could cause contamination of a medicine or allied substance with dirt or filth or could render the medicine or allied substance injurious or dangerous to health; "permit" means an agro-veterinary shop permit issued under section 29 of the Act; and "responsible person" means a person who has the control and management of an agro-veterinary shop.
PART II (1) A person shall apply to the Authority for a permit in Form I set out in the First Schedule. (2) The Authority shall, within 14 days of the receipt of an application, notify the applicant of the decision of the Authority in respect of the application. (3) A separate application shall be made and a separate permit issued in respect of each premises. (4) The Authority may inspect the premises in respect of which an application for a permit is made to determine if the applicant meets the requirements of the Act and the guidelines issued by the Authority. The Authority may request an applicant to submit information in relation to an application for a permit in Form II set out in the First Schedule. 5. Rejection of application for permit (1) The Authority shall reject an application for a permit if- (a) the applicant fails to meet the requirements of the Act and the guidelines issued by the Authority; (b) the permit issued to the applicant was revoked by the Authority within a period of two years preceding the application; or (c) the applicant is convicted of an offence under the Act or any other relevant written law. (2) The Authority shall, where it rejects an application under sub-regulation (1), inform the applicant within seven days of the decision in Form III set out in the First Schedule. (1) The Authority shall, where the applicant meets the requirements of the Act and the guidelines issued by the Authority, issue a permit in Form IV set out in the First Schedule. (2) A permit shall be valid for two years from the date of issue. (3) A permit may be issued in respect of the following classes of agro-veterinary shops- (a) Class I, to stock for sell the veterinary medicines and allied substances specified in Part A of the Second Schedule; (b) Class II, to stock for sale the veterinary medicines and allied substances as specified in Part B of the Second Schedule; and (c) Class III, to stock for sale the veterinary medicines and allied substances specified in Part C of the Second Schedule. (4) The classes of agro-veterinary shops shall be managed as follows- (a) Class I, by a registered veterinary surgeon or pharmacist; (b) Class II, by a registered veterinary para-professional under the supervision of a registered veterinary surgeon or pharmacist; and (c) Class III, by a suitably qualified person as determined by the Authority. 7. Application for renewal of permit (1) An application for the renewal of a permit shall be made to the Authority in Form V set out in the First Schedule. (2) The Authority shall, within 14 days of receipt of an application for the renewal of a permit, grant the application if the applicant meets the requirements of the Act and the guidelines issued by the Authority and has complied with the terms and conditions of the permit. (3) A permit that is not renewed by the Authority lapses on its date of expiry. (1) A permit shall be used solely by the holder and is not transferable to any other person without the prior approval of the Authority. (2) An application for approval to transfer a permit shall be made to the Authority in Form VI set out in the First Schedule. (3) The Authority shall, within 30 days of receipt of an application for the transfer of a permit, approve the transfer if the applicant meets the requirements of the Act and the guidelines issued by the Authority and issue the transferee with a new permit. (4) The Authority shall reject an application for the transfer of a permit if the applicant fails to comply with the conditions for the grant of the permit, the provisions of the Act and the guidelines issued by the Authority. (5) The Authority shall, where it rejects an application to transfer a permit under sub-regulation (4), inform the applicant in Form III set out in the First Schedule. (1) The Authority may amend a permit where- (a) some other person succeeds to the interest of the business of the holder; (b) the name of the business changes; or (c) there is a change in the employment of the responsible person. (2) An application for the amendment of a permit shall be made in Form VII set out in the First Schedule. (3) The Authority shall communicate its decision to the permit holder within 14 days of receipt of the application for amendment of the permit. (4) The Authority shall, where it approves the amendment of a permit, issue the applicant with a new permit. 10. Application for duplicate permit A person may, where a permit is lost, damaged or defaced, apply to the Authority for a duplicate permit in Form VIII set out in the First Schedule. (1) The Authority shall suspend a permit if- (a)the holder operates the agro-veterinary shop in respect of which it is issued under insanitary conditions; (b) the holder or manager of the agro-veterinary shop in respect of which it is issued obtains or sells veterinary medicines from unauthorised suppliers or stocks and sells unauthorised products; (c) the agro-veterinary shop in respect of which it was issued contravenes the prescribed standards or the provisions of the Act; (d) the agro-veterinary shop is not managed or controlled by a responsible person determined by the Authority; (e) the responsible person fails to maintain the required records on veterinary medicines and allied substances; (f) the agro-veterinary shop stocks and sells medicines that are not on the prescribed list; or (g) the holder contravenes the terms and conditions of the permit, the provisions of the Act or any other relevant written law. (2) The Authority shall, before suspending a permit, give notice to the holder of the intention to suspend the permit and request the holder to show cause, within a specified period, why the permit should not be suspended. (3) A notice of intention to suspend a permit shall be in Form IX set out in the First Schedule. (4) The Authority shall suspend a permit if the holder of the permit fails to take remedial measures within the period specified in the notice issued under sub-regulation (2). (5) A notice of the suspension of a permit shall be in Form X set out in the First Schedule. (6) The Authority shall, during the period of the suspension of the permit, quarantine any product affected by the suspension of the permit at the cost of the permit holder. (1) The Authority shall revoke a permit if the holder- (a) contravenes the provisions of the Act or any other relevant written law or breaches the terms or conditions of the permit; (b) fails to take corrective measures following the suspension of the permit within the specified period; (c) changes the agro-veterinary shop premises without authorisation; or (d) obtained the permit by fraud or deliberate or negligent submission of false information or statements. (2) The Authority shall, before revoking a permit, give notice to the holder of the permit of the intention to revoke the permit and request the holder to show cause, within a specified period, why the permit should not be revoked. (3) A notice of the intention to revoke a permit shall be in Form IX set out in the First Schedule. (4) The Authority shall revoke a permit if the holder fails to take remedial measures during the period specified by the Authority. (5) A notice of the revocation of a permit shall be in Form X set out in the First Schedule. (6) Upon the revocation of a permit, the medicines and allied substances on the premises shall be quarantined and disposed of as directed by the Authority at the holder's cost. 13. Location of agro-veterinary shop The Authority shall, in considering an application for a permit, give priority to submissions filed by the applicants in the following areas- (a) rural areas and districts where access to medicines is limited; and (b) peripheral areas of municipalities or cities, where access to medicines is limited. 14. Identity of agro-veterinary shop An agro-veterinary shop shall fix a standard logo for purposes of identifying the agro-veterinary shop as specified in the guidelines issued by the Authority. 15. Sale of veterinary medicines A holder of a permit shall sell the veterinary medicines prescribed in the Second Schedule. 16. Sale, supply and dispensing of veterinary medicines Veterinary medicines shall be sold, supplied and dispensed in accordance with the guidelines issued by the Authority. 17. Storage of veterinary medicines (1) The storage of veterinary medicines in an agro-veterinary shop shall be in the manufacturer's original container and under conditions stipulated by the manufacturer. (2) Where veterinary medicines are transferred to another container, care shall be taken to protect the integrity of the product and prevent contamination of the medicines. (3) The Authority shall, where it is established that the holder of a permit stocks veterinary medicines or products under insanitary conditions, direct the holder to dispose of the veterinary medicines or products at the holder's cost.
PART III 18. Register of agro-veterinary shop permits (1) The Authority shall keep and maintain a register of agro-veterinary permits in Form XI set out in the First Schedule. (2) The register referred to in sub-regulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times and upon payment of an inspection fee prescribed in the Third Schedule.
[Regulations 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12] PRESCRIBED FORMS Form I [Regulation 3(1)] (To be completed in triplicate)
Form II [Regulation 4]
Form III [Regulations 5(2) and 8(5)]
Form IV [Regulation 6]
Form V [Regulation 7(1)] (To be completed in triplicate)
Form VI [Regulation 8(2)] (To be completed in triplicate)
Form VII [Regulation 9] (To be completed in triplicate)
Form VIII [Regulation 10] (To be completed in triplicate)
Form IX [Regulations 11(3) and 12(3)] (To be completed in triplicate)
Form X [Regulations 11(5) and 12(5)] (To be completed in triplicate)
Form XI [Regulation 18]
[Regulations 16(3) and 15(1)] VETERINARY PRODUCTS FOR AGRO-VETERINARY SHOPS
MEDICINES AND ALLIED SUBSTANCES (DISPENSING CERTIFICATES) REGULATIONS [Section 28] Arrangement of Regulations Regulation PART I PART II 3. Application for certificate 5. Rejection of application for certificate 7. Application for renewal of certificate 10. Application for duplicate certificate PART III 15. Register of dispensing certificates SI 11 of 2016.
PART I These Regulations may be cited as the Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016. In these Regulations, unless the context otherwise requires- "authorised supplier" means a holder of a pharmaceutical licence issued under section 34 of the Act; and "certificate" means the dispensing certificate issued under section 28 of the Act.
PART II 3. Application for certificate (1) A person shall apply to the Authority for a certificate in Form I set out in the Schedule. (2) The Authority shall, within 14 days of the receipt of an application, notify the applicant of the decision of the Authority in respect of the application. (3) A separate application shall be made and a separate certificate issued in respect of each health facility. (4) The Authority may inspect the health facility in respect of which an application for a certificate is made to determine if the applicant meets the requirements of the Act and the guidelines issued by the Authority. (5) The Authority shall consider the following matters in determining an application for a certificate- (a) the number of health facilities in the area; (b) the classification of the health facility; and (c) the competence of the health practitioners responsible for dispensing the medicines. The Authority may request an applicant to submit information in relation to an application for a certificate in Form II set out in the Schedule. 5. Rejection of application for certificate (1) The Authority shall reject an application for a certificate if- (a) the applicant fails to meet the requirements of the Act and the guidelines issued by the Authority; (b) the certificate issued to the applicant was revoked by the Authority within the preceding two years before the date of the application; (c) the applicant's practising certificate is withdrawn by the relevant professional body; or (d) the applicant is convicted of an offence under the Act or any other relevant written law. (2) The Authority shall, where it rejects an application under sub-regulation (1), inform the applicant within seven days of the decision in Form III set out in the Schedule. (1) The Authority shall, where the applicant meets the requirements of the Act and the guidelines issued by the Authority, issue a certificate in Form IV set out in the Schedule. (2) A certificate shall be valid for two years from the date of issue. 7. Application for renewal of certificate (1) An application for the renewal of a certificate shall be made to the Authority in Form V set out in the Schedule. (2) The Authority shall, within 14 days of the application for a certificate, renew the certificate if the applicant meets the requirements of the Act and the guidelines issued by the Authority and has complied with the terms and conditions of the certificate. (3) A certificate that is not renewed by the Authority lapses on its date of expiry. A certificate shall be used solely by the holder and is not transferable to any other person. (1) The Authority may amend a certificate where the name of the business changes. (2) An application for the amendment of a certificate shall be made in Form VI set out in the Schedule. (3) The Authority shall, where it approves an application for the amendment of a certificate, issue the applicant with a new certificate. 10. Application for duplicate certificate A person may, where a certificate is lost, damaged or defaced, apply to the Authority for a duplicate certificate in Form VII set out in the Schedule. (1) The Authority shall suspend a certificate if- (a)the holder dispenses medicine under insanitary conditions; (b) the holder or manager of the health facility in respect of which it is issued obtains or sells medicines from unauthorised suppliers or stocks and sells unauthorised products; (c) the health facility does not comply with good dispensing practices determined by the Authority; (d) the holder fails to maintain the required records on medicines and allied substances; or (e) the holder contravenes the terms and conditions of the certificate or the provisions of the Act or any other relevant written law. (2) The Authority shall, before suspending a certificate, give notice to the holder of the intention to suspend the certificate and request the holder to show cause, within a specified period, why the certificate should not be suspended. (3) A notice of intention to suspend a certificate shall be in Form VIII set out in the Schedule. (4) The Authority shall suspend a certificate if the holder of the certificate fails to take remedial measures within the period specified in the notice issued under sub-regulation (3). (5) A notice of the suspension of a certificate shall be in Form IX set out in the Schedule. (6) During the period of the suspension of the certificate- (a) the product affected by the suspension of the certificate shall be quarantined and disposed of at the cost of the certificate holder; and (b) the health facility to which it relates shall not dispense medicines, except for emergency cases. (7) The Authority shall lift the suspension of a certificate where the holder complies with the terms and conditions of the suspension. (1) The Authority shall revoke a certificate if the holder- (a) contravenes the provisions of the Act or breaches the terms or conditions of the certificate; (b) fails to take corrective measures following the suspension of the certificate within the specified period; (c) obtained the certificate by fraud or deliberate or negligent submission of false information or statements; or (d) fails to comply with any other relevant written law. (2) The Authority shall, before revoking a certificate, give notice to the holder of the certificate of the intention to revoke the certificate and request the holder to show cause, within a specified period, why the certificate should not be revoked. (3) A notice of the intention to revoke a certificate shall be in Form VIII set out in the First Schedule. (4) The Authority shall revoke a certificate if the holder fails to take remedial measures during the period specified by the Authority. (5) A notice of the revocation of a certificate shall be in Form IX set out in the Schedule. (6) Upon the revocation of a certificate, the products in the health facility shall be quarantined or disposed of as directed by the Authority at the holder's cost. (1) Medicines in a health facility shall be dispensed in accordance with the guidelines issued by the Authority. (2) A holder of a dispensing certificate who undertakes dispensing activities shall stock medicines of the required quality, safety and efficacy. (3) A patient may request a medical practitioner for a written prescription to enable the patient obtain medicines from any other health facility of their choice. (1) The storage of medicines in a health facility shall be in the manufacturer's original container and under conditions stipulated by the manufacturer. (2) The Authority shall, where it determines that the holder of a certificate stocks medicines or products under insanitary conditions, direct the holder to dispose of the medicines or products at the holder's cost. (3) Where medicines are transferred to another container, care shall be taken to protect the integrity of the product and prevent contamination of the medicines.
PART III
15. Register of dispensing certificates (1) The Authority shall keep and maintain a register of dispensing certificates in Form X set out in the Schedule. (2) The register referred to in sub-regulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times and upon payment of a prescribed inspection fee.
[Regulations 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 15] PRESCRIBED FORMS Form I [Regulation 3(1)] (To be completed in triplicate)
Form II [Regulation 4]
Form III [Regulation 5(2)]
Form IV [Regulation 6]
Form V [Regulation 7(1)] (To be completed in triplicate)
Form VI [Regulation 9(2)] (To be completed in triplicate)
Form VII [Regulation 10] (To be completed in triplicate)
Form VIII [Regulations 11(3) and 12(3)]
Form IX [Regulations 11(5) and 12(5)]
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