Statutory Instrument of 2006. Medicines and Allied Substances Control (Gloves) Regulations, 2006 _____________________________________________________________________ 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
(1) These regulations may be cited as the Medicines and Allied Substances Control (Gloves) Regulations, 2006.
Regulation 2 · Interpretation
In these regulations - “form” means the appropriate form set out in the First Schedule; “glove” means - (b) a surgical glove which is sterile, anatomically shaped medical glove finger rather than lying flat, and intended for use in invasive surgery; (e) any other glove as determined by the Authority.
Regulation 3 · Application
These regulations shall apply to gloves used or intended for use for any medical purposes.
Regulation 4 · Sale of unapproved gloves prohibited
(1) No person shall sell any gloves unless such glove is of a type which has 1 been approved by the Authority. (2) In approving a type of glove in terms of subsection (1) the Authority may fix any conditions it considers necessary or desirable.
Regulation 5 · Applications for approval of types of gloves
Any person who wishes to obtain the approval of the Authority for a type of glove shall apply to the Authority, in duplicate, in Form M.C.G. 1 and such application shall be accompanied by - (a) the fee specified in section 13; and (b) the appropriate number of samples as required by the Second Schedule.
Regulation 6 · Notification of approved types of gloves
Where the Authority approves a type of glove the Director-General shall cause to be published in the Gazette notification of such approval.
Regulation 7 · Gloves to meet standards
No glove shall be approved by the Authority unless such glove meets the standards as set out in the Second Schedule or as specified by the Authority in guidelines from time to time.
Regulation 8 · Labelling of gloves
Each package of gloves shall state thereon - (a) the name of manufacturer and place of manufacture; and (b) the date of manufacture; and (c) the batch number; and (d) the date of expiry, if any; and (e) the size of gloves; and (f) the methods of sterilization, if any; and (g) any warnings; and (h) the type of lubrication; and (i) the intended use.
Regulation 9 · Storage of gloves
No person who stores for sale any glove shall expose such glove to heat in excess of twenty-eight degrees Celsius, moisture, direct sunlight or fluorescent lighting.
Regulation 10 · Distribution of unapproved gloves prohibited
(1) No importer, manufacturer or wholesaler, as the case may be, shall sell 2 any glove unless the batch of which such gloves 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.G. 2.
Regulation 11 · 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 of glove in terms of section 5.
Regulation 12 · Withdrawal of gloves
Where the Authority is of the opinion that the withdrawal of any batch of gloves is necessary for the protection of the public, the Authority may require any person to withdraw such batch of gloves in accordance with the procedure as determined by the Authority.
Regulation 13 · Fees
(1) The fee payable in respect of an application for the approval of a type of glove shall be one hundred thousand dollars. (2) Any costs incurred in testing any gloves for the purpose of obtaining approval in terms of section 4 or subsection (2) of section 10 from the Authority shall be borne by the importer, manufacturer or wholesaler, as the case may be.
Regulation 14 · Sale of expired gloves prohibited
No person shall sell any glove on a date later than the expiry date, which appears on the package of such glove.
Regulation 15 · Penalties
Any person who contravenes these regulations shall be guilty of an offence and liable to a fine not exceeding level seven or to imprisonment for a period not exceeding six months or to both such fine and such imprisonment. 3
FIRST SCHEDULE (Section 2)
MEDICINES AND ALLIED SUBSTANCES CONTROL ACT [CHAPTER 15:03] Medicines and Allied Substances Control (Gloves) Regulations, 2006 An application in terms of section 5 of the Medicines and Allied Substances Control To be sent to the Director-General, Medicines Control Authority of Zimbabwe, P O Box 10559, 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. 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 ……………………………………………………………………………………….. ……………………………………………………………………………………….. 4 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 glove and other distinguishing marks …………………………… ………………………………………………………………………………………… 11. State how glove is packed …………………………………………………………….. …………………………………………………………………………………………. 12. State how gloves 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 gloves (e.g. glue, crimping, etc.) …… …………………………………………………………………………………………. 14. State the specifications of the gloves…………… ……………………………………. …………………………………………………………………………………………. 15. State the specifications of the glove as per Part I of the Second Schedule to the Medicines and Allied Substances Control (Gloves) Regulations, 2006 ………………. …………………………………………………………………………………………. 16. Give details and explanations of all codes on the packaging which appear on an individual pack of gloves …………………………………………………………….. …………………………………………………………………………………………. 17. State number of samples submitted for testing as required by Part II of the Second Schedule to the Medicines and Allied Substances Control (Gloves) Regulations, 2006 …………………………………………………………………………………………. 18. I enclose the application fee of ……………………………………… and undertake to pay the cost for any tests conducted on the gloves and enclose herewith a deposit of ……………………….. towards the cost for testing the gloves. I, the undersigned, hereby declare that all the information contained herein and in the attachments is correct and true. Date: ………………………………. ……………………………………. * Delete the inapplicable 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. 5 MEDICINES AND ALLIED SUBSTANCES CONTROL ACT [CHAPTER 15:03] Medicines and Allied Substances Control (Gloves) Regulations, 2006 An application in terms of subsection (2) of section 10 of the Medicines and Allied Substances Control (Gloves) Regulations, 2006. To be sent to the Director-General, Medicines Control Authority of Zimbabwe, P O Box 10559, 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 of glove ………………………………………………….. 9. Type of glove ………………………………………………………………………… 10. Batch number to be approved ………………………………………………………… 11. Date of manufacture of batch ………………………………………………………… 12. I enclose a deposit of ……………………………………… towards the cost for testing the gloves. 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. 6
SECOND SCHEDULE (Section 7)
1. SAMPLING AND SELECTION OF TEST PIECES Gloves shall be sampled and inspected in accordance with ISO 2589-1. The inspection levels and acceptable quality levels (AQLs) shall conform to those specified in Table 1 for the characteristics listed. When a lot size cannot be determined, a lot of 35 001 to 150 000 shall be assumed. Table 1 - Inspection Levels and AQLs Characteristic Inspection Level AQL Physical dimensions (width, length, S-2 4,0 thickness Watertightness S-4 2,5 Tensile strength and elongation at break S-2 4,0 (before and after accelerated ageing) 2. DIMENSIONS Gloves shall comply with the inspection level and AQL given in Table 1 and the dimensions for palm width and length given in Table 2. Table 2 - Dimensions and Tolerances DIMENSION Size, mm Palm Width 70 80 95 110 120 + 10 Length 230 all sizes min. Thickness at For all sizes:- Palm and Finger: Smooth area textured 0.08 min. area 0.11 min. 3. WATERTIGHTNESS When tested for watertightness, there should be no leakage, using the inspection level and AQL given in Table 1. 7 Gloves shall be tested by introducing 1 000cm3 50cm3 of water at a maximum temperature of 36C into a holding device designed to hold the glove in a vertical position when filled with water. The glove shall be observed for leakages for 3 minutes. 4. TENSILE PROPERTIES Requirements on tensile properties for quality control purposes apply to new gloves only. Tensile properties shall be measured in accordance with ISO 37, taking a minimum of three test pieces from each glove and using the median value as the test result. Gloves shall comply with the inspection level and AQL given in Table 1 and the requirements given in Table 3. Table 3 - Tensile Properties Property Unit Requirement1 Minimum tensile strength Mpa 21 before ageing Minimum elongation at % 700 break before accelerated ageing Minimum tensile strength Mpa 16 after accelerated ageing Minimum elongation at % 500 break after accelerated ageing 1 If it is necessary for the test piece to be taken from a textured portion, then the requirement shall be 10% lower than those given in this table. 8