Marketing, Manufacturing, Packaging & Labeling, Advertising
Marketing, manufacturing, packaging & labeling, advertising in Zimbabwe – an overview. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
- The process is set out in the Medicines Control Authority of Zimbabwe (Guidelines on Submission of Documentation for Registration of Complementary Medicines) and Section 9 of the Medicines Control Authority of Zimbabwe Guidelines for Advertising and Promotion of Medicine in Zimbabwe.
- An application form together with a dossier of supporting documents has to be submitted to the registration department at the Medicines Control Authority of Zimbabwe (MCAZ). The Licensing and Advertising Committee of the Authority considers all advertising material submitted for approval. The Committee meets regularly on the first Tuesday of every month.
- Advertisements must be submitted at least two weeks prior to the meeting to ensure they are included on the agenda for the next meeting.
- To facilitate the review process applicants are encouraged to limit the indications claimed to the following:
- Those derived from data already submitted to the Authority during registration of the product that have been substantiated and approved.
- The Authority reserves the right to limit the claims made on advertisements directed to the public. Applicants should not use the advertisement before written approval is given.
- For printed material ONE colour copy and NINETEEN other good copies should be submitted. The Authority may reject any unsatisfactory copies.
- The advertisements should always contain the following and any other requirements as may be deemed necessary by the Authority.
- Standard warnings where applicable. These should be of a large enough size
- To be easily readable on the advertisement or be read loud enough to be heard by listeners or displayed long enough to be seen by viewers respectively.
- Approved Name(s) and strength of all the active ingredient(s) per unit dose should be stated.
- Name and address of manufacturer or distributor.
- The registration number and category for distribution should be indicated.
- If approved/disapproved, the Authority issues an approval/disapproval letter, which is then communicated, to the customer.
- In addition, in accordance with the provisions of Section 6 of Part II of the Fifth Schedule of the Broadcasting Services Act [Chapter 12:06]: “(2) A broadcaster must not broadcast an advertisement relating to a medicine unless the text of the proposed advertisement has been approved –
- by the Secretary for Health and Child Welfare under subparagraph (3); or
- by the Minister on appeal to the Minister under this paragraph.
- A person may apply, in writing, to the Secretary for Health and Child Welfare for approval of the text of a proposed advertisement relating to a medicine.
- If an application is made, the Secretary for Health and Child Welfare may, in writing, approve or disapprove the text”.
The above power may be delegated to the Medicines Control Authority of Zimbabwe, which has a Licensing and Advertising Committee.
2. What is the authorization process for the marketing of generic versions of these products?
- In accordance with the MCAZ Guidelines on Submission of Documentation for Registration of a Multisource (Generic) finished pharmaceutical product, the process is the same as above.
- However, Applications for generic solid dosage forms (tablets, capsules, suspension and the like) medicines may require the submission of a bio-equivalence study.
3. What are the typical fees for marketing approval?
The typical fees for the approval of advertisements or promotional material is $50.00 as provided for in the MCAZ Circular on Payment of Fees (REF B/279/35/12/12018).
NB. The fee is set out in United States dollars, but following the enactment of the Finance (No 2) Act of 2019, all Acts and Regulations which sounded in United States dollars, now sound in Zimbabwe dollars at a parity rate. In some instances, however, Regulatory bodies and Government departments have been authorised to charge foreign companies and individuals in foreign currency, so it is possible that the currency of payment may vary.
4. What is the period of authorization and the renewal process?
- In accordance with the provisions of Section 34 of the Regulations, once a medicine has been registered, the registration remains in effect until it is cancelled, subject, however, to the payment of an annual fee.
- In accordance with Section 11 of the Regulations, The period of authorization for a person or premises in respect of manufacturers, pharmacies, pharmacists, and pharmacy technicians is twelve months. An application for the renewal shall be lodged with the Director-General, in triplicate, in Form M.C. 3 for the renewal of a license for premises and in Form M.C. 4 for the renewal of a license for a person before the expiry of such license and shall be accompanied by the appropriate fee in respect of each license.
- Where an application for the renewal of a license has been lodged with the Director-General, the validity of the license shall, where the applicant has not been given notice of the renewal or refusal of the application by the date of expiry of such license, continue after the date of expiry until the decision of the Authority on the application is notified to the applicant by the Director-General.
5. What are the requirements, if any, for post-approval pharmacovigilance?
The pharmacovigilance activities are coordinated by the MCAZ in collaboration with the Ministry of Health and Child Care (MoHCC) and all key stakeholders both in the public and private health sector including the pharmaceutical industry. Healthcare professionals are to consider pharmacovigilance practice as a professional responsibility (see http://www.mcaz.co.zw/index. php/how-we-regulate/ pharmacovigilance/pharmacovigilance-centre).
There is, however, no statutory post approval pharmacovigilance protocol required by MCAZ.
6. Are foreign marketing authorizations recognized?
As per the Medicines Control Authority of Zimbabwe (Guideline on submission of documentation for registration of complementary medicines), foreign marketing authorisations are recognised.
However, one has to list the countries in which
- The FPP (Finished Pharmaceutical Product) has been granted a marketing authorisation,
- The FPP has been withdrawn from the market,
- An application for the marketing of the FPP has been rejected, deferred or withdrawn.
7. Are parallel imports of medicines or devices allowed?
This is not legislated in Zimbabwe.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
This is not legislated in Zimbabwe.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The manufacturing of medicines and devices is regulated by Medicines Control Authority of Zimbabwe (MCAZ). It is regulated in terms of the Act and the Regulations.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?
As per the MCAZ Good Manufacturing Practice Guidelines published on 10 December 2019, all prospective and licensed pharmaceutical manufacturers, as well as international pharmaceutical manufacturers who have medicines registered in Zimbabwe, must comply with the World Health Organisation Good Manufacturing Practice.
11. What is the inspection regime for manufacturing facilities?
The MCAZ conducts inspections in line with current WHO GMP guidelines. Upon submission of an application of a medicine with the Authority, the manufacturer should request for inspection of their site through email: firstname.lastname@example.org and the request should be accompanied with an updated site master file and list of products submitted for registration. A pro forma invoice will henceforth be issued and dates for inspection will be scheduled upon receipt of payment for the inspection.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
There is no provision for the same under Zimbabwean law.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
This process is set out in Sections 3 – 6 of the MCAZ Guidelines for Good Wholesaling Practice of Pharmaceuticals.
BUILDINGS & GROUNDS
- Warehousing of pharmaceuticals should be carried out in buildings or parts of buildings that have been built for, or adapted to, this purpose.
- The grounds should be established and maintained so as to minimize ingress into the buildings of dust, soil or other contaminants and should be maintained in an orderly condition. They should be free of accumulated waste, dirt and debris. Waste should be collected in designated closed containers and disposed of at frequent intervals.
- Buildings should be kept free of rodents, vermin, birds, pets and pests.
- Buildings should provide protection for the pharmaceuticals from contamination and deterioration, including protection from excessive local heating or undue exposure to direct sunlight. The pharmaceuticals received or dispatched at receiving or dispatch bays, platforms or areas should also be protected from dust, dirt and rain.
- Buildings should have sufficient security to help prevent misappropriation of the pharmaceuticals.
- Sufficient space should be provided for the orderly receipt, warehousing and dispatch of pharmaceuticals and, in particular, a quarantine area for isolation when necessary, including isolation of faulty packs and recalled goods. Each area in the wholesale should be physically separated and demarcated.
- Buildings and fixtures should be kept clean and well maintained. Cleaning equipment should be stored in hygienic conditions.
- Sufficient lighting should be provided to enable all operations to be carried out accurately and safely.
- Storage facilities should protect goods from deterioration. The conditions of storage for the goods should be compatible with the storage conditions specified on their labels. All pharmaceuticals should be stored off the floor.
- Controlled storage environments, e.g. deep freeze, refrigeration, should be monitored, using suitable temperature recording devices and the records reviewed and filed. Refrigerated and freezing storage environments should be fitted with signals to indicate that refrigeration has failed. The signal should permit resetting only by an authorized person.
- Temperatures in other areas where goods requiring specific storage conditions are held should be monitored and the results tabulated and analysed to demonstrate the suitability of these areas for their purposes.
- If any temperature is found to have deviated outside the relevant recommended conditions for an extended time, the manufacturer of the goods should be consulted and the suitability of the product for use resolved.
- Instruments or equipment used for monitoring temperature should be calibrated on a regular basis to ensure their accuracy. Records for the calibration should also be kept on the premises.
- Special storage facilities should be provided for drugs of addiction, “Dangerous Drugs” as required by the legislation.
- Incompatible activities such as manufacture (including repackaging) or the handling of toxic chemicals should be avoided in areas in which pharmaceuticals are handled by wholesale.
- Pharmacists or Pharmacy Technicians bearing the responsibility for ensuring that products/materials are correctly handled, stored and distributed, should have the education, training experience or combination of these elements that will allow them to effectively discharge this responsibility.
- Operating personnel should be trained to perform assigned duties and functions at an acceptable level. Records of any training relevant to their functions should be kept.
- Procedures and job descriptions for employees and other persons having access to the products must be designed and administered to minimize the possibility of drugs coming into unauthorized possession.
- During operating hours, the business must at all times be conducted under the continuous personal supervision of a licensed pharmacist or licensed pharmacy technician.
- Premises dealing in dangerous drugs should be under the supervision of a licensed pharmacist.
STOCK HANDLING AND STOCK CONTROL
- Handling and storage of pharmaceuticals should be in accordance with established procedures designed to prevent contamination or deterioration, damage to packs or confusion of products. Particular care should be given to maintaining the integrity of seals on packs of sterile pharmaceuticals. Attention should be paid to any special instructions from the manufacturer relating to handling or storage of the pharmaceuticals.
- Importers should take all reasonable measures to ensure that pharmaceuticals are not mishandled or exposed to adverse storage conditions at ports of entry e.g. airports.
- Storage areas should be adequate and organized to permit segregation and identification of the various materials and products stored and should enable stored goods to be easily maintained in a clean, dry and orderly condition. Particular care should be taken to avoid mould growth in refrigerated rooms or cabinets.
- There should be a system to ensure stock rotation, with frequent regular checks that the system is operating correctly. The system should ensure that pharmaceutical products due to expire first are sold and/or distributed first (FEFO). Where no expiry dates exist for the products, the FIFO principle should be applied. Products beyond their expiry date or shelf life should be removed from usable stock and neither sold nor supplied.
- Spilled substances should be cleaned up promptly and rendered safe as quickly as practicable and under the supervision of a responsible person. A written procedure for dealing with spillage of items of special hazard, such as cytotoxic drugs, should be available.
- Measures should be taken to demonstrate that restricted goods are not misappropriated.
- Goods bearing an expiry date must not be received or supplied after their expiry date or so close to their expiry date that this date is likely to occur before the goods are used by the consumer. Such goods must be withdrawn from sale and quarantined pending disposal in accordance with agreements between the wholesaler and the supplier.
- Precautions must be taken to prevent unauthorized persons from entering storage areas. Areas with medicines should be kept locked in the absence of the supervisor to restrict access by unauthorized persons.
14. What information must be included in medicine and device labeling?
As set out in Section 37(1) of the Regulations:
- The name of the active ingredient(s) using either international non-proprietary names (INN) or the approved generic name of the drug;
- The brand name;
- Content of active ingredient(s) per dosage form or regimen;
- Name of other ingredients known to cause problems;
- Approved therapeutic uses;
- Dosage form or regimen;
- Side-effects and major adverse drug reactions;
- Precautions, contraindications and warnings;
- Name and address of manufacturer or distributor;
- Reference to scientific literature as appropriate.
15. What additional information may be included in labeling and packaging?
- Generally, no person shall sell any registered medicine unless it is labelled with its registered name and registered number, in addition to any other prescribed requirements. Where a medicine is required by this Act to be labelled with any information, such information shall be written, printed or otherwise marked on a label which is attached or affixed to the package of that medicine ; or packed with and refers to that medicine. The Authority may, if it deems it expedient, direct that the name and address of the manufacturer of a particular medicine shall not appear on the packages. Every medicine shall, where possible, be marked with the house mark of the principal or manufacturer of the medicine, as the case may be, and such other distinguishing mark for the purpose of identifying such medicine according to Section 37 (3) of the Regulations.
In terms of Section 60 of the Regulations, every person who dispenses a prescription preparation shall label such prescription preparation with—
- The registered name, strength and form of the medicine;
- Provided that this shall not apply where the prescriber has indicated that the prescription preparation shall not be so labelled: and
- The total quantity of the medicine; and
- The directions for use; and
- Any warnings; and
- The name of the patient; and
- The name of the prescriber;
- The name of the manufacturer; and
- The prescription reference number allocated to the prescription by the person dispensing the medicine; and
- The date on which the prescription preparation is supplied; and
- The name and address of the supplier.
16. What items may not be included in labeling and packaging?
- Generally, claims concerning medicinal drugs should be reliable, accurate, truthful informative, balanced, up-to-date, capable of substantiation and in good taste. They should not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug use or to give rise to undue risks. The word “safe” should only be used if properly qualified. Comparison of products should be factual, fair and capable of substantiation.
- This is in accordance with Section 6 of the MCAZ Guidelines for Advertising and Promotion of Medicines in Zimbabwe.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
The Restriction on the advertisement of medicines is provided for in terms of Section 65 the Regulations. Those restrictions are amplified by the Guidelines for advertising and promotion of medicines in Zimbabwe (the Advertising Guidelines). The provisions provide as follows:
- Advertising of medicines is only permitted where the Medicines Control Authority of Zimbabwe (the Authority) has given authority;
- The offering of bonuses or discounts for the purchase of medicines in advertisements is prohibited;
- Advertising is not permitted if it is calculated to lead to the use of medicines for the following conditions:
Alcoholism, Appendicitis, Arteriosclerosis, Cardiovascular disease, Cataract, Diabetes, Hernia, Kidney stone, Pneumonia, Prostate gland disorders, Epilepsy, Gallstones, Gangrene, Glaucoma, Hypertension, Hypotension, Infantile diarrhoea, Plague, Pleurisy, Locomotors or any other ataxia, All types of meningitis, Nephritis, Osteoarthritis, Sexually transmitted infections, Pneumoconiosis, Multiple sclerosis, Rheumatic fever, Rheumatoid arthritis, Malignant disease, Thrombosis, Tuberculosis, Poliomyelitis, Parkinson’s disease.
The exception to this prohibition is where the advertisement of the above medicines are directed at medical or veterinary professionals. This still requires the approval of the Authority.
- Advertising of psychotropic substances or any medicine which contains codeine or any of any of its salts is not permitted. This includes the window display for cough and cold preparations.
- Registered medicines may only be available to the public on the direction of a medical practitioner; dental practitioner or veterinary surgeon. Such medicines can only be advertised in a medical, dental, veterinary of pharmaceutical journal approved by the Authority.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
In terms of Section 50 of the Regulations, no person shall sell any medicine unless the sale is effected on premises –
- licensed in terms of Part V1of the Act; or
- authorized in terms of these regulations;
- authorized by a general dealer’s license issued in terms of the Shop Licenses Act [Chapter 14:17].
The requirements for the licensing of premises are provided for in terms of the Third Schedule of the Regulations. The schedule provides that the premises or planned premises must demonstrate the following standards:
- satisfactory cleanliness. lighting, ventilation, tidiness, security, toilet facilities, washable impervious floor, washable painted walls and shelves;
- wash hand basin and sink with hot and cold water;
- storage of medicines; adequate protection from light, heat, moisture; prescription preparations to be out of reach of public; special storage place for dangerous medicines, namely fixed and lockable cupboards;
- equipment; sufficient and adequate measures, balance and weights*; adequate refrigeration, mortar and pestle*, counting tray spatulas, sterilizing facilities;
- prescription recording system: satisfactory prescription record (e.g. microfilm, computer, photocopy or patient profile cards or other approved recording system);
- reference books: satisfactory reference books (e.g. latest Martindale, or British National Formulary, or next to latest British Pharmacopoeia or latest Pharmaceutical Codex or other approved references);
- legislation: The Act as amended and up to date regulations made there-under; Dangerous Drugs Act [Chapter 15:02] as amended and up to date regulations made thereunder;
- containers: cardboard cartons, vial, bottles (plastic/glass) and no other containers whatsoever unless approved by the Authority in writing; stock bottles for tablets, capsules and liquids;
- any other requirements as may be required by the Authority.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
In terms of Section 2 of the Act, ‘advertisement’ is defined as:
“in relation to any medicine, means any written, pictorial, visual or other descriptive matter or verbal statement or reference—
- appearing in any newspaper or other publication; or
- appearing on any television or cinematograph film; or
- distributed to members of the public; or
- brought to the notice of members of the public in any manner whatsoever; which is intended to promote the sale of that medicine.
There are no separate requirements for electronic marketing and advertising via email or via social media of medicines.
20. May medicines and devices be advertised or sold directly to consumers?
Medicines can be sold and advertised directly to consumers but with certain limitations. In terms of Section 40(1) of the Act, any false or misleading advertisement concerning a medicine is not permitted.
In terms of Section 40(2) of the Act where a condition is placed on the sale of any medicine, such as that such medicine can only be sold with a prescription by a doctor or dental surgeon, no one may advertise medicine in a manner that suggests that such condition does not apply.
In addition to the above, the Advertising Guidelines provide that:
- Advertisements to the general public should help people to make rational decisions on the use of medicines determined to be legally available without a prescription;
- Language which brings about fear or distress should not be used.
- Advertisements should be reliable, accurate, truthful, informative, balanced, up-to-date, and capable of substantiation and in good taste.
- While they should take account of people’s legitimate desire for information regarding their health, they should not take undue advantage of people’s concern for their health.
- Bonus offers and discounts offered directly to the public are not permissible. However:
- Point of sale indication of a price reduction may be permitted for medicines in the HR, HR (Vet), VMGD and P categories.
- Indication of the selling price of medicines in the HR, HR (Vet) and VMGD categories may be permitted. Indication of a price reduction is however not permitted.
- Medicines can be sold directly to consumers. However, in terms of Section 17(1) of the Regulations, medicine can only be sold from registered premises, such premises being under the supervision of a registered pharmacist.
- In terms of Section 78(2) (a) of the Regulations a pharmacist may sell any medicine that does not require a medical practitioner’s prescription at the request of any person, subject to the condition that the pharmacist, by or under whose supervision the medicine is sold, before he delivers such medicine, makes an entry in his records stating –
- the name and address of the person requesting the medicine and the person for whom it is intended; and
- if the person is under the age of 12 years, the person’s age; and
- the date on which the medicine is sold; and
- the registered name, quantity, form and strength of the medicine; and
- the total daily dose of the medicine; and
- the directions for use
21. How is compliance monitored?
For the purposes of ensuring compliance with the various provisions relating to medicines, the Authority may appoint inspectors and analysers. In terms of Section 65 of the Act inspectors are appointed for the proper enforcement of the Act and (analysts as it may for the purposes of the testing, examination or analysis of medicines in terms of the Act.
In terms of Section 66 of the Act, the inspectors have the following powers:
- To enter upon and search any premises, place, vehicle, vessel or aircraft at or in which there is or is on reasonable grounds suspected to be any medicine or any substance, device or articles;
- To inspect any medicine or any substance, device or article to which any relevant regulations apply or any book, record or document found in or upon such premises, place, vehicle, vessel or aircraft;
- To seize any such medicine, substance, device or article or any books, records or documents found in or upon such premises, place, vehicle, vessel or aircraft and appearing to afford evidence of a contravention of any provision of this Act;
- To take so many samples of any such medicine, substance, device or article as he may consider necessary for the purpose of testing, examination or analysis in terms of the Act;
- To enter any premises in respect of which an application for a license has been made in terms of the Act or which has been licensed in terms of the Act or which the inspector has reasonable grounds for believing are being used for the manufacture of a medicine or the carrying on of the business of a pharmacist in contravention of the Act.
22. What are the potential penalties for noncompliance?
Where the Authority is of the opinion that violations of the Act or its regulations have occurred it will invite comments from the person affected. Where no comments are submitted from the person required to submit his or her comments or after consideration of any comments submitted by the person concerned, the Authority is of the opinion for any reason specified that the license concerned should be cancelled or suspended or the purposes for which the license was issued should be altered or the conditions subject to which the license was issued should be varied, the Authority may direct the Director- General to:
- to cancel the license and impose a period of disqualification not exceeding three years during which the person concerned shall not be issued with a license; or
- to suspend the license; or
- to alter the purposes for which the license was issued; or
- to vary the conditions subject to which the license was issued.
There are also criminal penalties which may be imposed under Section 67 of the Act, and include penalties for:
- hindering or obstructing an inspector
- influencing a person under the age of 18 to use medicine in contravention of the Act,
- selling to or procuring medicine for a person under the age of 18,
- making misleading or false statements in an application for registration of any medicine, in connection with any medicine, in the course of selling any medicine of for purposes of the Act,
- selling medicines in containers on which there is a false or misleading statement regarding the contents,
- for the purpose of business, publishing any reports or certificates issued by an inspector, or
- selling or using for gain any veterinary medicine for the treatment of a person.