Marketing, Manufacturing, Packaging & Labeling, Advertising
Marketing, manufacturing, packaging & labeling, advertising in Algerian Pharma – an overview. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, 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?
To obtain market authorization for new drugs, biologics and medical devices in Algeria, submission of application to Ministry of Health is required, and must be accompanied by a submission dossier that includes clinical data. Authorization process is detailed in answer to question 3 of “Regulatory, Pricing, and Reimbursement Overview”.
There is no specific authorization process for over-the counter (OTC) medications according to Article 230 of Health Law No 18-11, dated of 2 July 2018, defined within the same law as drugs that could be dispensed through authorized community pharmacies without prior physician prescription, and whose list is established by Ministry of Health.
Under Health Law No 18-11 provisions, some dietary supplements and herbal products could be considered as drugs, and are therefore assessed by Ministry of Health.
2. What is the authorization process for the marketing of generic versions of these products?
Market authorization process for generic products is the same as for brand-name products, except that generic products are in general exempted from submitting pharmacological, toxicological and clinical tests. The Ministry of Health could request that the in vivo bioequivalence of the generic product be demonstrated against the brand-name product already on the market.
3. What are the typical fees for marketing approval?
Marketing approval fees for new drugs, biologics, and medical devices are fixed as part of Finance Law. They depend of the product type, importance and origin (imported or locally manufactured). As at July 2019, the current authorization fees are ranging between 100.000 DZD and 1.000.000 DZD (approx. 835 to 8.350 USD). Fees amount is detailed in answer to question 4 of “Regulatory, Pricing, and Reimbursement Overview”.
4. What is the period of authorization and the renewal process?
Market authorization is granted for a period of five years. For renewal process details, see answer to question 5 of “Regulatory, Pricing, and Reimbursement Overview”.
5. What are the requirements, if any, for post-approval pharmacovigilance?
The market authorization holder is obliged to notify any identified event related to the product safety that occurred locally or abroad, including those supposedly attributable to vaccination, and must report regularly or upon request to the National Center for Pharmacovigilance and Materiovigilance (“CNPM” – “Centre National de Pharmacovigilance et de Matériovigilance”), created by Decree No 98-192 dated of 3 June 1998 and published in the Official Gazette.
The CNPM missions include:
- Monitoring adverse reactions due to the use of drugs on the market and incidents or risks of incidents resulting from the use of medical devices.
- Carrying out any study or research related to the safety of use of drugs and medical devices during administrations and various uses to perform prophylactic, diagnostic and therapeutic acts.
6. Are foreign marketing authorizations recognized?
Yes. Foreign marketing authorizations are recognized and required for imported products under provisions of Decree No 92-284 dated of 6 July 1992, published in the Official Gazette, and related to registration of pharmaceutical products for human use. The foreign market authorization applicant in Algeria has to designate a reference market abroad (referred at as country of origin).
In addition, a valid Certificate of Pharmaceutical Product issued by the competent regulatory authorities of country of origin in the format recommended by the World Health Organization + copy of valid marketing authorization in country of origin and/or CE marking certificate (for medical devices) are required as part of initial submission dossier and for the 5-year renewal.
Nevertheless, imported drugs, biologicals and medical devices cannot be marketed in Algeria unless they have been granted authorization by Ministry of Health (“registration decision” for drugs and biological, “homologation decision” for medical devices, according to Article 230 of Health Law No 18-11, dated of 2 July 2018).
7. Are parallel imports of medicines or devices allowed?
No. All imported products must be authorized in Algeria before entering the national territory, and no entity, other than importers authorized by Ministry of Health, is allowed to import any drug or medical device in Algeria.
Authorized importers receive an annual permit for a defined list of products granted by Ministry of Health, and should comply with technical requirements for the import of drugs and medical devices for use in human medicine set by Ministerial Decree dated of 30 October 2008, published in the Official Gazette.
Products intended for “compassionate use” under the regimen of temporary authorization for use (“ATU” – “Autorisation Temporaire d’Utilisation”) require the prior authorization granted by Ministry of Health under provisions of Article 233 within Health Law No 18-11, when they are prescribed as part of the management of serious diseases in situations where there is no equivalent treatment in the national territory, and have proven their therapeutic benefit.
Non-registered products used locally as part of clinical trials approved protocols are also requiring special authorization for import, issued by Ministry of Health according to Article 389 of Health Law No 18-11.
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?
According to Article 27 of Decree No 92-286 dated of 6 July 1992, related to scientific and medical information on pharmaceutical products for human use, and published in the Official Gazette, manufacturers, importers, promotion companies, medical representatives are prohibited from giving or allowing directly or indirectly to give bonuses, objects or products of any kind, or material benefits of any nature whatsoever to health professionals and practitioners. However, scientific activities as well as congresses, seminars and meetings can benefit from donations, or material and financial support, subject to a prior declaration to Ministry of Health.
Under provisions of Article 237 within Health Law No 18-11, free medical samples for advertising and promotion are now expressly prohibited from being offered to health professionals and practitioners.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
Health Law No 18-11, dated of 2 July 2018, along with Decrees No 93-114 dated of 12 May 1993, and No 92-285 dated of 6 July 1992, related to authorization of pharmaceutical products manufacturing and distribution sites, published in the Official Gazette, form the legislative framework for manufacturing of drugs, biologicals and medical devices in Algeria.
Compliance of the activities carried out by manufacturers is monitored and evaluated by Ministry of Health, at which “ANPP” – “Agence Nationale des Produits Pharmaceutiques”, a financially independent agency newly created by Article 223 of Health Law No 18-11, dated of 2 July 2018, will gradually replace former “DGPES” – “Direction Générale de la Pharmacie et des Equipements de Santé”, upon its establishment.
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)?
Yes. Local manufacturing requirements refer to the GMPs as defined by the European Medicines Agency, and to those of U.S. Food & Drug Administration as guidance. Therefore, the requirements are compatible.
11. What is the inspection regime for manufacturing facilities?
Under Health Law No 18-11, all manufacturers have an obligation to accept GMP compliance inspection by the Algerian Ministry of Health, at the time of examination of market authorization, and within every five years thereafter. Inspections could also be conducted at any time, with or without prior notice, to inspect premises and verify compliance with the local regulatory requirements.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Despite the fact that there are no specific regulations on this matter, foreign inspectors (including US FDA/EMA) and third-party inspectors are performing inspections in local manufacturing facilities, especially for toll manufacturing contracting and in context of export.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
Conducting of these activities is strictly limited to pharmaceutical establishments defined in the Health Law No 18-11 as companies organized according to the legal forms provided for by Commercial Code, and subject to the prior approval of Ministry of Health competent services.
Manufacturers and importers undertake to distribute the drugs and medical devices exclusively to wholesalers who are duly authorized, inspected and distributed throughout the national territory. At the same time, wholesalers commit to source the products only from authorized manufacturers or importers that are inspected by Ministry of Health.
Technical management of all authorized pharmaceutical establishments is put under the responsibility of a pharmacist technical director fulfilling the conditions of professional qualification and exercise set by regulation. His main duty is to insure the satisfactory compliance with the Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs) requirements.
14. What information must be included in medicine and device labeling?
a) For drugs:
The internal and external packaging must include the following mentions, easily legible, in apparent and indelible characters in Arabic and in French:
- trade name;
- International Nonproprietary Name (INN) printed in large print or, failing that, the usual name;
- registration decision number in Algeria;
- date of manufacture, by printing the first three letters of the month and the year;
- expiry date by printing the first three letters of the month and the year;
- pharmaceutical form;
- centesimal formula with precise indications of active substances;
- active ingredient content per unit and per package;
- lot number;
- manufacturing site and the country of origin;
- particular conditions of storage and conservation;
- special conditions of dispensation (registration on lists I or II);
- duration of stability in the case of a preparation to be reconstituted;
- name and address of the manufacturer;
b) For medical devices:
The internal and external packaging must comply with international standards in force and bear the following words, in Arabic and in French:
- name of the product;
- nature of the product, if any;
- method of use of the product, if any;
- technical characteristics;
- sterilization method;
- particular conditions of storage;
- dates of manufacture and expiry;
- lot number;
- particulars, especially for sterile medical devices (non-reusable);
- name and address of the manufacturer.
Each drug or medical device must be accompanied by a leaflet easily legible, written in Arabic and in French, and containing, in addition to the information required above, the following information:
- therapeutic indications;
- adverse effects;
- warnings, if any;
- precautions for use, if any;
- drug interactions, if any;
- duration of stability in the case of a preparation to be reconstituted;
- name and address of the manufacturer’s registered office;
- other particulars necessary for the proper use of the product, including oral form, chewable, diluted solution, etc.
15. What additional information may be included in labeling and packaging?
Addition information is not specified in regulations, but false, exaggerated or misleading information is expressly prohibited to be included in labeling and packaging. In general, all relevant information that may help to a better understanding of the information (pictograms, icons, different colors and elements of design, etc…), and lead to the best possible use of the drug or medical device is accepted by Ministry of Health.
16. What items may not be included in labeling and packaging?
Are prohibited from being included in labeling and packaging all items that are not strictly concordant with the information submitted by the market authorization holder and approved by Ministry of Health, including all false, disguised, misleading, indirect, subliminal, or unfair information, as well as indication, usage, administration, or expiration information which are not approved in Algeria.
Besides that, tags cannot be affixed to the packaging to correct or add information except those related to authorized public price and reimbursement status that are attached by manufacturers or importers in accordance with regulatory requirements.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
Under local regulations, scientific information on pharmaceutical products is considered as mandatory, and is defined as information that must be accurate, verifiable and in accordance with the latest data from medical and scientific research, at the time of its release. It is intended, in particular, for health professionals and users in order to ensure the proper use of pharmaceutical products.
Scientific information must necessarily mention the International Nonproprietary Name (INN) of the product that is the subject of this information, and can only be carried out for pharmaceutical products duly authorized by the Ministry of Health competent services.
Whereas advertising for pharmaceutical products to healthcare professionals is defined in regulations as any activity aiming to promote prescription and dispensing of the advertised products. Advertising must not be misleading or detrimental to the protection of public health. It must present the drug or product objectively and promote its proper use. It must respect the provisions of the market authorization as well as the therapeutic strategies recommended by Ministry of Health.
Advertising can only be carried out for regularly authorized pharmaceutical products, and is prohibited when the drug is re-evaluated by Ministry of Health for the benefit-risk ratio.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
Approved drugs and medical devices are solely sold to consumers at authorized community pharmacies or dispensed through hospital pharmacies, based on physician prescription (except for over-the-counter medications).
According to Algerian regulations, especially provisions of Article 16 of Decree No 92-286 dated of 6 July 1992, related to scientific and medical information on pharmaceutical products for human use, and published in the Official Gazette, no drug or medical device can be sold or delivered via post or other channels.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
There are no specific regulations for advertising through electronic channels to health professionals. Requirements for those channels are the same as for conventional ones and prior technical visa of Ministry of Health is required.
20. May medicines and devices be advertised or sold directly to consumers?
Under the Health Law No 18-11 provisions, marketing and advertising for pharmaceutical products to the public are prohibited regardless of the channel used. Advertising of over-the-counter (OTC) medications is also limited to health professionals, and is subject to prior technical visa of Ministry of Health which sets the list of these products.
According to Article 179 within the same law, OTC medications can be directly sold to consumers, without prior medical prescription, but only via authorized community pharmacies channel.
21. How is compliance monitored?
Scientific information and advertising on pharmaceutical products are allowed to be conducted by pharmaceutical manufacturers directly, or through duly authorized companies specialized in medical promotion. Both must be established under Algerian law to conduct these activities.
May also be authorized to perform scientific information and advertising on pharmaceutical products for non-promotional purposes:
- Public institutions whose vocation is related to public health, training and scientific research in the field of health when the public health needs require it;
- Scientific associations for their training activities;
- Associations of social nature and in particular consumer protection associations for their health education activities.
In all cases, scientific information and advertising on pharmaceutical products are subject to prior authorization granted by Ministry of Health.
22. What are the potential penalties for noncompliance?
According Health Law No 18-11 provisions, anyone who contravenes the law provisions relating to scientific information and advertising on pharmaceutical products, is liable to a fine of 200.000 DZD to 500.000 DZD (approx. 1.670 to 4.175 USD). In the event of a second offense, the fine is doubled.
Any manufacturing, operating, import, export or distribution of pharmaceutical products by structures not approved by the competent services, is punishable by imprisonment of five (5) years to ten (10) years and a fine of 5.000.000 DZD to 10.000.000 DZD (approx. 41.750 to 83.500 USD).
Anyone who contravenes prohibition to the manufacture, brokerage, distribution, advertisement, offer for sale, sale, import, export or possession of falsified pharmaceutical products is punishable by imprisonment of five (5) years to ten (10) years and fine of 1.000.000 DZD to 5.000.000 DZD (approx. 8.350 to 41.750 USD).