Statutory Instrument 183 of 2005. Medicines and Allied Substances Control (Condom) Regulations, 2005 _____________________________________________________________________ IT is hereby notified that the Minister of Health and Child Welfare has, in terms of section 74 and after consultation with the Authority in terms of section 38, of the Medicines and Allied Substances Control Act [Chapter 15:03], made the following regulations: -
Regulation 1 · Title
These regulations may be cited as the Medicines and Allied Substances Control (Condom) Regulations, 2005.
Regulation 2 · Interpretation
In these regulations - “condom” means a medical device which is intended to be worn on the penis during sexual activity for purposes of contraception and to prevent the spread of sexually transmitted infections. “form” means the appropriate form set out in the First Schedule.
Regulation 3 · Sale of unapproved condoms prohibited
(1) No person shall sell any condoms unless such condom is of a type and brand which has been approved by the Authority. (2) In approving a type and brand of condom in terms of subsection (1) the Authority may fix any conditions it considers necessary or desirable.
Regulation 4 · Condoms to meet standards
No condom shall be approved by the Authority unless such condom meets the standards as set out in the Second Schedule or as specified by the Authority in guidelines from time to time. 1
Regulation 5 · Applications for approval of types and brands of condoms
Any person who wishes to obtain the approval of the Authority for a type and brand of condom shall apply to the Authority, in duplicate, in Form M.C.Con.1 and such application shall be accompanied by - (a) the fee specified in section 14; and (b) the appropriate number of samples as required by the Authority.
Regulation 6 · Notification of approved types and brands of condoms
Where the Authority approves a type and brand of condom the Director- General shall cause to be published in the Gazette notification of such approval.
Regulation 7 · Packaging of condoms
(1) Every condom shall be sealed in an individual pack which shall state thereon the date of manufacture of such condom and the date of expiry. (2) Each package of condoms shall state thereon the name and address of the manufacturer of such condom.
Regulation 8 · Storage of condoms
No person who stores for sale any condom shall expose such condom to heat in excess of twenty-eight degrees Celsius, moisture, direct sunlight or fluorescent lighting.
Regulation 9 · Distribution of unapproved batches of condoms prohibited
(1) No importer, manufacturer or wholesaler, as the case may be, shall sell any condom unless the batch, of which such condom is a part, has been approved for distribution by the Authority. (2) Any person who wishes to obtain the approval of the Authority in terms of subsection (1) shall apply to the Authority, in duplicate, in Form M.C. Con. 2. (3) Where the Authority approves a batch of condoms, such batch may be sold for such period as determined by the Authority.
Regulation 10 · Shelf life of condoms
(1) No person shall sell any condom, which is more than thirty-six months old from the date of manufacture. Provided that in the case of a type and brand of condoms whose shelf life exceeds thirty six months the manufacturer concerned shall supply satisfactory stability data on such type and brand of condoms. (2) No person shall import any condom, which has less than six months of its shelf life remaining. 2
Regulation 11 · Sale of expired condoms prohibited
No person shall sell any condom on a date later than the expiry date, which appears on the package of such condom.
Regulation 12 · Notification of change of particulars
Every person shall without delay inform the Authority of any alteration from the information or particulars furnished by him in applying for approval for a type and brand of condom in terms of section 5.
Regulation 13 · Withdrawal of condoms
Where the Authority is of the opinion that the withdrawal of any batch of condoms is necessary for the protection of the public, the Authority may require any person to withdraw such batch of condoms in accordance with the procedure as determined by the Authority.
Regulation 14 · Fees
(1) The fee payable in respect of an application for the approval of a type and brand of condom shall be two hundred thousand dollars. (2) Any costs incurred in testing any condoms for the purpose of obtaining approval in terms of section 5 or 9 shall be borne by the importer, manufacturer or wholesaler, as the case may be.
Regulation 15 · Penalties
Any person who contravenes these regulations shall be guilty of an offence and liable to a fine not exceeding three thousand dollars.
Regulation 16 · Repeals
The Drugs and Allied Substances Control (Condom) Regulations, 1991, published in Statutory Instrument 147 of 1991, are repealed. 3
FIRST SCHEDULE (Section 2)
MEDICINES AND ALLIED SUBSTANCES CONTROL ACT [CHAPTER 15:03] An application in terms of section 5 of the Medicines and Allied Substances Control (Condom) Regulations, 2005. To be sent to the Director-General, Medicines Control Authority of Zimbabwe, P O Box 10559, Union Avenue, Harare, or to be lodged at the offices of the Director-General, Medicines Control Authority of Zimbabwe, 106 Baines Avenue, Harare. Samples and printed matter to be forwarded by post or other means and carriage, customs duty and clearance to be paid and effected by the applicant in all instances. Notes 1. The application fee and any other relevant documents are required to be attached to the application. If the fee or document required to be attached is not attached, the application cannot be accepted. 2. If insufficient space is provided in the application attach a sheet of paper with the additional information. 3. If the form or any part of the form is illegible or not properly completed the application will be rejected. 1. Particulars of applicant: If a sole proprietor: Full names: ……………………………………………………………………………………… ….…………………………………………………………………………………… If a company: Name of company: …………………………………………………. ………………………………………………………………………………………. 2. Business, Physical and postal addresses: ………………………………….…………………………………………………… ………………………………………………………………………………………. ………………………………………………………………………………………. ……………………………… Telephone number: ………………………………… Fax number: ………………… E-mail address…………………………………….. 3. Registered office ……………………………………………………………………. 4. Name and designation of person completing and signing form …………………..… ……………………………………………………………………………………….. 5. Name under which business is conducted ………………………………………….. ……………………………………………………………………………………….. 6. Name and physical address of manufacturer ………………………………………… 4 ………………………………………………………………………………………… 7. State whether there may be any alternative places/sources of manufacture other than that referred to in item 6. YES/NO*. IF YES, state the name(s) and address(es) of the other manufacturers ……………………………………………………………………………………….. ……………………………………………………………………………………….. 8. Name and address of importer (if different from item 1 or 2) ………………………… ……………………………………………………………………………………….. 9. Name and address of distributor (if different from item 1 or 2) ……………………. ……………………………………………………………………………………….. 10. State trade mark of condom and other distinguishing marks ……………………….. ……………………………………………………………………………………………. 11. State how condom is packed ……………………………………………………………..……………………………… …………………………………………………………………………………………….. 12. State how condoms will be offered for sale in packs or packages to - (a) an importer ………………………………………………………………………… (b) a wholesaler ……………………………………………………………………….. (c) retailer ………………….…………………………………………………………. (d) members of the public ……………………………………………………………. 13. State the type of sealing for individual packs of condoms (e.g. glue, crimping, etc.) …………………………………………………………………………………………… …………………………………………………………………………………………… 14. State the specifications of the condoms including shelf life …………………………………………….……………………………………………… ……………………………………………………………………………………………. 15. Summary of methods used to ensure compliance with specifications …………………………………………………………………………………………. …………………………………………………………………………………………. 16. Give details and explanations of all codes on the packaging which appear on an individual pack of condoms ……………………………………………………………..……………………………… …………………………………………………………………………………………….. 17. State number of samples submitted for testing …………………………………………………………………………………………. 18. I enclose the application fee of ……………………………………… and undertake to pay the cost for any tests conducted on the condoms and enclose herewith a deposit of ……………………….. towards the cost for testing the condoms. I, the undersigned, hereby declare that all the information contained herein and in the attachments is correct and true. Date: ………………………………. ……………………………………………… * Delete the inapplicable 5 MEDICINES AND ALLIED SUBSTANCES CONTROL ACT [CHAPTER 15:03] Medicines and Allied Substances Control (Condom) Regulations, 2005 An application in terms of section 9 of the Medicines and Allied Substances Control (Condom) Regulations, 2001. To be sent to the Director-General, Medicines Control Authority of Zimbabwe, P O Box 10559, Union Avenue, Harare, or to be lodged at the offices of the Director-General, Medicines Control Authority of Zimbabwe, 106 Baines Avenue, Harare. Samples and printed matter to be forwarded by post or other means and carriage, customs duty and clearance to be paid and effected by the applicant in all instances. 1. Particulars of applicant: If a sole proprietor: Full names: ………………………………………………………………………………………. If a company: Name of company: …………………………………………………. ………………………………………………………………………………………. 2. Business/Physical and postal addresses: …………………………………………… ………………………………………………………………………………………. Telephone number:………… Fax number: ……E-mail address…………………… 3. Registered office …………………………………………………………………….. 4. Name and designation of person completing and signing form ……………………. ……………………………………………………………………………………….. 5. Name under which business is conducted ………………………………………….. ……………………………………………………………………………………….. 6. Name and physical address of manufacturer ………………………………………… ………………………………………………………………………………………… 7. Name and address of importer (if different from item 1 or 2) ……………………………………………………………………………………….. 8. Approval number of type and brand of condom……………………………………... 9. Type and brand of condom…………………………………………………………… 10. Batch number to be approved ………………………………………………………… 11. Date of manufacture of batch ………………………………………………………… 12.Shelf life………………………………………………………………………………. 13. I enclose a deposit of ……………………………………… towards the cost for testing the condoms . I, the undersigned, hereby declare that all the information contained herein is correct and true. Date: ………………………………. ……………………………………. Note: 1. An analyst or an inspector duly authorized by the Authority will visit your premises to obtain random samples from the batch concerned for the purpose of testing them.
SECOND SCHEDULE (Section 4)
6 TEST BATCH SIZE SAMPLE SIZE NON COMPLIERS Dimensions 10 000 - 35 000 8 0 Package Seal 10 000 - 35 000 20 1 Air inflation 10 000 - 35 000 125 Pressure____5__ Water Pinhole 10 000 - 35 000 125 1 7 REQUIREMENTS SECTION SAMPLING VERIFICATION Performance Requirements Burst volume before and after oven 3.2 ISO 2859-1, Level G-1 Laboratory testing conditioning AQL 1.5 Burst pressure before and after oven 3.2 ISO 2859-1, Level G-1 Laboratory testing conditioning AQL 1.5 Freedom from holes 3.2 ISO 2859-1, Level G-1 Laboratory testing Visible defects 3.2 ISO 2859-1, Level G-1 Laboratory testing Design Requirements Shape and texture 3.3 Agreed upon between Visual inspection Integral bead 3.3 Agreed upon between Visual inspection Colour 3.3 Agreed upon between Visual inspection Scents and flavouring 3.3 Agreed upon between Sensory inspection Width 3.3 ISO 2859 – 1, Level S-2 Laboratory testing Length 3.3 ISO 2859 – 1, Level S-2 Laboratory testing Thickness 3.3 ISO 2859 – 1, Level S-2 Laboratory testing Lubricant quality (including powder) 3.3 ISO 2859 – 1, Level S-2 Laboratory testing Packaging requirements Individual package 3.3 ISO 2859 – 1, Level S-3 Visual testing * AQL = Acceptable Quality Level 8