Marketing, Manufacturing, Packaging & Labeling, Advertising
The legal framework for marketing, manufacturing, packaging & labeling, advertising in Nigerian Pharma. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, 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?
NAFDAC is the body responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, biologics, medical devices, chemicals and other medicinal product in Nigeria. Consequently, none of the foregoing items, whether locally produced or imported is to be used, marketed or advertised in Nigeria without prior registration with NAFDAC.
The Guidelines for Advertisement of NAFDAC Regulated Products in Nigeria (The Guidelines), is the principal enactment governing the advertisement and marketing of regulated products in Nigeria.
In terms of the guidelines, registration of a product or item with NAFDAC does not automatically confer an advertising permit. A separate application and subsequent approval by NAFDAC shall be required if the product is to be advertised. For purposes of effective management of time, the guidelines allow a simultaneous submission of registration and advertisement applications to NAFDAC.
In advertising pursuant to the regulation, the following restrictions are operative under the NAFDAC Regulations:
- Consumer promotions are not allowed for medicinal products.
- Prescription-Only-medicines (POM) may be advertised only in Medical/ Scientific Journals and such advertisement materials must contain abridged prescribing information including composition, indication, dosage, administration, adverse effects, drug interactions, contraindications, warnings and precautions.
- All herbal medicinal products (without established clinical studies) and advert materials shall include the caveat, “These claims have not been evaluated by NAFDAC”
- Advertisements of Over-the-Counter (over) drugs are to include the Caveat “If Symptoms Persist after 3 Days, Consult Your Doctor/Physician”.
- A vetting approval would also have to be obtained from the Advertising Standards Panel (ASP), a statutory committee of the Advertising Practitioners Council of Nigeria (APCON), where the manufacturer intends to advertise its products in Nigeria.
2. What is the authorization process for the marketing of generic versions of these products?
The authorization process for the marketing of the generic versions of new drugs, biologics, medical devices, over the Counter medications and other medical products is the same as above. Generic versions of these drugs do not require a different process for its marketing as this can be done through a single application process.
3. What are the typical fees for marketing approval?
The fees chargeable by NAFDAC for an application for advert approval are set out in the Guidelines. The fees typically is ₦10,000 (Ten Thousand Naira) per product, per medium, per concept, per language while the cost of renewal is at ₦6,000 (Six Thousand Naira) per product, per medium, per concept, per language. These fees are subject to VAT at 5%.
4. What is the period of authorization and the renewal process?
The Guidelines provides that the timeline for the processing of an application for advertisement or marketing is 20 working days.
All adverts when approved are valid for one year from the date of the approval. Although the process for renewal of an advert license is not stipulated in the Guidelines, in practice, all the prior documents submitted for the grant of the initial approval in addition with the evidence of initial approval are the documents to be submitted to NAFDAC for the renewal of the approval. This is usually carried out before the expiration of the existing approval.
5. What are the requirements, if any, for post-approval pharmacovigilance?
The NAFDAC Good Pharmacovigilance Practice Guidelines 2016 prescribes several compliance requirements for the holder of a product marketing approval. These prescriptions are primary for the solving and reconciliation of any development on the approved product that may impugn on the potency or other aspects of the products.
NAFDAC requires an efficient risk management of the medicinal products by the holder of the marketing license. This is achieved by a production of a Risk Management Plan (RMP) as provided by the 2016 Guidelines. A RMP requires the input of different specialists and departments within and/or outside an organization; typically, the safety specification may require involvement of toxicologists, pharmacoepidemiologists, clinical pharmacologists, clinical research physicians and pharmacovigilance experts. The input required for the pharmacovigilance plan may require any of these experts depending upon the safety concerns identified in the safety specification and the types of activities planned to address them.
Since a risk management plan is primarily a pharmacovigilance document, ideally the production of it should be managed by personnel with appropriate pharmacovigilance training. Regardless of who prepares the RMP, the responsibility for the content and accuracy of the RMP remains with the marketing authorisation applicant/holder who should ensure oversight by someone with the appropriate scientific background within the company:
The RMP consists of seven parts:
- The product(s) overview
- Safety specification
- Pharmacovigilance plan
- Plans for post-authorisation efficacy studies
- Risk minimisation measures (including evaluation of the effectiveness of risk minimisation measures)
- Summary of the risk management plan
A holder/applicant of a marketing approval as a step in pharmacovigilance is responsible for: ensuring that it constantly monitors the risks of its medicinal products and reports the results of this, as required, to NAFDAC; while taking all appropriate actions to minimise the risks of the medicinal product and maximise the benefits including ensuring the accuracy of all information produced in relation to its medicinal products, and actively updating and promptly communicating when new information becomes available.
6. Are foreign marketing authorizations recognized?
Foreign marketing authorizations in so far they relate to advertisements are not recognized. Drugs, drugs products and or medical devices whether or not it has an advertisement license or approval in other jurisdictions are still subject to the application requirements before an advert approval by NAFDAC for such products or device can be advertised or marketed in Nigeria. Also, Drugs that have been registered in foreign jurisdictions will nonetheless mandatorily have to be registered in Nigeria with NAFDAC in line with the Food and Drugs Act and other Regulations before they can be imported, sold, distributed or used in Nigeria.
7. Are parallel imports of medicines or devices allowed?
There exist no particular law which favours a recognition of parallel imports of medicines, drugs, or devices in Nigeria.
However as has already been highlighted in the preceding chapters, there is a restriction on the importation of any drug into Nigeria without the prior approval of NAFDAC, such consent or approval by NAFDAC takes the form of registration of the drugs to be imported. For such approval for importation to be granted to a potential importer of drugs or devices by NAFDAC, the Agency as one of its mandatory requirements requires that evidence of the written consent and or authority of the manufacturer of the product to such importer must be presented to NAFDAC where any other person or entity other than the manufacturer makes an application for the registration. Such authorization is usually in the form of a power of Attorney which is issued by the manufacturer of the drugs or medical device and must state the names of the products to be registered, the ownership of brand names and trademarks registered in Nigeria.
Also, in the Trade Marks Act, Section 5 (2) of the Act confers on the owner of the registered mark, the exclusive right to use the trade mark in marketing or selling his goods. The Act also confers on the registered owner of the trade mark the right to initiate an action to seek redress for infringement of his trade mark if a person not being a permitted user of the trademark uses the mark in relation to any goods in respect of which the trademark is registered.
The above provisions thus unwittingly prohibit and disallows the parallel import of medicines or devices in Nigeria which has as its chief trait the absence of consent or knowledge of such importation on the part of the registered owner of the trademark.
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?
In Nigeria, the Medical and Dental Practitioners Act together with the Code of Medical Ethics are the chief laws regulating the conduct of medical practitioners in Nigeria. These bodies of laws also regulate the practice of medicine in different healthcare centers.
Both the Code and the Act do not make provision for the regulation of the nature, manner of involvement or restriction of a medical practitioner in marketing or promotional activities of drugs or drug products. It is thus not unusual to see medical practitioners being entertained at events hosted by drug manufacturers or being handed customized gifts in such events.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
NAFDAC has the sole responsibility for the regulation of the manufacture of Medicines and related products, this power is conferred on it by the provisions of the Food Drugs and Related Products (Registration, Etc) Act, and several Guidelines and Regulations made pursuant to the Act.
NAFDAC exercises its power of control and regulation by approving all manufacture of medicines and related products before they can be passed on to the consumer for consumption or use. NAFDAC, backed by the provisions of the Good manufacturing practice Guidelines for Pharmaceutical products 2016 regulates the manufacture of these products by ensuring that the following essential elements are in existence and all necessary facilities for GMP are provided including:
- Appropriately qualified and trained personnel;
- Adequate premises and space;
- Suitable equipment and services;
- Appropriate materials, containers and labels;
- Approved procedures and instructions;
- Suitable storage and transport;
- Adequate personnel, laboratories and equipment for in-process controls;
In a nutshell, Paragraph 1.2 of the Guidelines for pre-registration Inspection of Pharmaceutical Manufacturing Facilities in Nigeria provides that “drug product should not be manufactured in Nigeria unless the facility has been inspected, found to comply with Good Manufacturing Practices and an Authority to Manufacture pharmaceutical products is issued by NAFDAC”.
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)?
Good Manufacturing Practices in Nigeria are regulated by NAFDAC pursuant to which it has issued the Good Manufacturing Practice Guidelines for Pharmaceutical Products. The Guidelines has robust provisions stipulating the minimum standards manufacturers are required to adhere to in order to ensure the quality of pharmaceutical products in the country. It also provides for: good manufacturing practice requirements; for methods, facilities and controls for the manufacture, processing, packaging or holding of a pharmaceutical product for human or animal use; and self-inspection.
In light of this, we are of the view that our local requirements are fairly compatible with good manufacturing practices defined by the U.S. Food & Drug Administration and European Medicines Agency. This is evident in the Guidelines issued by NAFDAC in this regard, which provide for similar provisions to these jurisdictions such as quality system and control, self-inspection by the manufacturing company at least once a year, etc.
11. What is the inspection regime for manufacturing facilities?
The NAFDAC Guidelines for Pre-Production inspection of Pharmaceutical Manufacturing Facilities in Nigeria provides that drug products should not be manufactured in Nigeria unless the facilities where they are to be manufactured have been inspected, found to comply with Good Manufacturing Practices and an Authority to Manufacture pharmaceutical products has been issued by NAFDAC.
The guidelines also prescribe the minimum requirements necessary for the issuance of an Authority to Manufacture Pharmaceutical products. The relevant guidelines are available on the NAFDAC website.
An application for Pre-Production Inspection should be made on the company’s letter-headed to The Director, Drug Evaluation & Research Directorate; with (i) Site Master File of the proposed facility; (ii) evidence of company incorporation; (iii) evidence of License to Practice of the Superintendent and Production Pharmacists by the Pharmacists Council of Nigeria (PCN); (iv) Company Quality Manual; and (v) validation Master Plan for the facility.
In addition to the above, self-inspection is included in NAFDAC’s Guidelines on Good Manufacturing Practice (GMP), whereby it is indicated that self-inspection must be conducted in order to monitor the implementation and compliance with GMP principles and to recommend necessary corrective actions. All self-inspections should be conducted in an independent and detailed manner by designated competent persons from the manufacturing company. It is provided that there must be at least one self-inspection in a year.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
This is currently not provided in the relevant guidelines or laws regulating the manufacturing in the pharmaceutical industry. Instead, what is envisaged is an inspection carried out by NAFDAC.
However, given that the relevant laws do not provide for an express restriction on approaching NAFDAC with a request for such allowance, a request may be made by a third-party or foreign inspection in this regard.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
The objectives of drug storage are to ensure stock security and the maintenance of the quality of drugs throughout their shelf life. The efficient and successful operation of a drug storage and distribution system requires the professional skills of pharmacists. Therefore, pharmacists are charged with the responsibility of overseeing the drug stores operated by federal, state and local governments as well as in the private sector.
It is expected that public and private sector establishments put adequate mechanisms in place to ensure that the temperature in all drug storage facilities is maintained at not more than 20oC for the sustenance of the shelf life of drugs. In respect of vaccines and biological products, pharmacists are expected to provide appropriate cold storage for the maintenance of the shelf life of such vaccines and products. Also, regular checks on the quality of stored drugs shall be undertaken to ensure that they do not deteriorate under storage conditions.
14. What information must be included in medicine and device labeling?
There are several specific requirements in relation to what must be included in labels of medicines and medical devices. It important to note that before a product can be registered with NAFDAC, it must have first approved the label or artwork of the product.
Labelling is regulated by the relevant NAFDAC guidelines for the registration of medicine or medical device. The following are the applicable labelling guidelines for drugs in Nigeria:
- the labeling should be informative and accurate.
- minimum requirements on the label are as follows:
➢ Name of product (brand name) where applicable and generic name.
➢ Name and full location address of the manufacturer.
➢ Provision for NAFDAC Registration Number on product label
➢ Batch No., Manufacturing date and Expiry date.
➢ Dosage form & strength
➢ Indications, frequency, route, conditions of administration (for OTC drugs).
➢ Dosage regimen on the package (for OTC drugs).
➢ Patient Information Leaflet (PIL)
➢ Prescribing information (for prescription only medications).
➢ Net content of product
➢ Quantitative listing of all the active ingredients per unit dose
➢ Adequate warnings where necessary.
➢ Where a brand name is used, there must be the generic name which should be conspicuous in character, written directly under the brand name.
Also, it is important to note that drug products whose name or package label bear close resemblance to an already registered product or is likely to be mistaken for such registered product, shall not be considered for registration. Further, any drug product which is labelled in a foreign language shall not be considered for registration by NAFDAC unless an English translation is included on the label and patient leaflet information (where applicable).
15. What additional information may be included in labeling and packaging?
In addition to the above requirements, medicines in containers of less than or equal to 10 ml capacity that are marketed in an outer pack such as a carton, and the outer pack bears all the required information, the immediate container need only contain:
- Name of the finished pharmaceutical product (i.e. (invented) name, strength, pharmaceutical form), active substance(s) and route(s) of administration.
- Route of administration
- Manufacturing Date
- Expiry date
- Batch number
- Contents by weight, by volume or by unit
- The name and address of the supplier (i.e. the manufacturer) if space permits otherwise the name of the manufacturer should be stated or a logo that unambiguously identifies the company.
- Directions for use, and any warnings or precautions that may be necessary.
16. What items may not be included in labeling and packaging?
Labelling and packaging link directly with the marketing of a product and in terms of Clause 5.2 of the Guidelines for Advertisement of NAFDAC Regulated Products in Nigeria, the labeling of all products must comply with the labelling requirement as registered. This implies that the label and package of the regulated product (which include medicines and medical devices) must not include any information that is in contravention of the information which was included in the original application to NAFDAC when the application for registration of the product was made.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
The starting point is that there is a requirement to obtain an advertisement approval from NAFDAC before any medicine or medical device can be marketed and advertised in Nigeria. The following are the applicable restriction on advertising of medicines and medical devices in Nigeria:
- Consumer promotions are not allowed for medicinal products. For medical devices on the other hand, consumer promotions are valid for only fifteen (15) weeks.
- Prescription-Only-medicines (POM) may be advertised only in Medical/ Scientific Journals.
- Advertisement materials for Prescription-only-Medicines (POM) must contain abridged prescribing information including composition, indication, dosage, administration, adverse effects, drug interactions, contraindications, warnings and precautions.
- Advertisement of Over-the-Counter (OTC) drugs are to include the Caveat “If Symptoms Persist after 3 Days, Consult Your Doctor/Physician”.
- All herbal medicinal products (without established clinical studies) and advert materials shall include the caveat, “These claims have not been evaluated by NAFDAC”.
- Section 2 of the Food and Drugs Act 1976 prohibits advertisements of drugs or device represented as treatment, preventive or cure for any of the diseases or disorders specified in the First Schedule to the Food and Drugs Act. The First Schedule of the Act contains a list of about sixty-five diseases and disorders and it includes alcoholism, cancer, obesity, sleeping sickness, acquired immune deficiency syndrome, diabetes, etc.
- Section 5 of the Food and Drugs Act prohibits advertisement of a drug in any manner that is false or misleading or is likely to create a wrong impression as to its quality, character, value, quality or safety.
In addition to obtaining an advertisement approval from NAFDAC, the manufacturer would be required to obtain a vetting approval from the Advertising Standards Panel (ASP), a statutory committee of the Advertising Practitioners Council of Nigeria (APCON). APCON was established by the APCON Act of 1988 and it is charged with the responsibility of regulating and controlling the practice of advertising in Nigeria.
Therefore, approval from both NAFDAC and APCON are required for the advertisement of medicines and medical devices in Nigeria.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
Medicines can be sold and delivered by licensed pharmacists registered with the Pharmacists Council of Nigeria (Pharmacist Council) at pharmaceutical premises duly registered with Pharmacists Council. Although the medicines are to be sold at the registered pharmaceutical premises, delivery may however be effected via post or any other means.
It is important to note that there are no express legal restrictions relating to delivery of medicines via post provided the sale was carried out at a registered pharmaceutical premises.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
Electronic marketing or advertisement via email, internet etc. are allowed in Nigeria subject to obtaining an advertisement approval from NAFDAC and a vetting approval from APCON.
To obtain advertisement approval from NAFDAC, the following documentation would be required:
- an application in writing on the applicant’s letter head addressed to the Director General of NAFDAC;
- duly completed prescribed application form;
- two copies of the receipt of purchase of the form;
- evidence of product registration with NAFDAC;
- a letter of introduction of Advert Agent from the applicant (where applicable); and
- telephone no. and email address of the directors of the applicant/Advert Agent.
The applicant would also be required to submit a script where the advertisement is to be aired online. The timeline for obtaining the advertisement approval is approximately twenty (20) working days from the date the application is submitted to NAFDAC.
20. May medicines and devices be advertised or sold directly to consumers?
Certain medicines and devices are prohibited from advertisements in Nigeria. Section 2 of the Food and Drugs Act 1976 prohibits advertisements of drugs or device represented as treatment, preventive or cure for any of the diseases or disorders specified in the First Schedule to the Food and Drugs Act. The First Schedule of the act contains a list of about sixty-five diseases and disorders and it includes alcoholism, cancer, obesity, sleeping sickness, acquired immune deficiency syndrome, diabetes, etc.
Medicines not covered by the above prohibition may however be advertised directly to consumers.
In relation to direct sale to consumers, there is no express prohibition in Nigeria on the sale of medicines and medical devices to consumers directly. Thus, it may be inferred that medicines and medical devices may be sold directly to consumers.
21. How is compliance monitored?
Compliance is monitored by the Investigation and Enforcement Directorate of NAFDAC. This directorate is responsible for ensuring compliance with NAFDAC’s mandate on regulatory activities. It receives and investigates complaints.
In addition to monitoring carried out by NAFDAC, APCON also has a Monitoring Unit which utilizes the services of media monitoring agencies. Also, members of APCON provide backup monitoring information to ensure that manufacturers conform to the provisions of the APCON vetting guidelines and other laws relating to advertising. Members of the public also monitor and report cases of unwholesome advertisements to APCON through ad-check numbers and e-mails.
22. What are the potential penalties for noncompliance?
Penalty imposed by NAFDAC
Failure to obtain advertisement approval from NAFDAC where a regulated product is to be advertised will make the manufacturer liable to sanctions. Also, where the failure is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of any director, manager, secretary or other similar officer of manufacturing company or any person purporting to act in any of those capacities, he, as well the company shall be deemed to be guilty of the offence and shall be liable on conviction to a fine of ₦100,000 (One Hundred Thousand Naira).
Penalty imposed by APCON
Failure to obtain vetting approval from APCON before exposure of the advertisement, will attract a minimum penalty of ₦500,000 (Five Hundred Thousand Naira).