Traditional Medicines and OTC Products
All legal aspects surrounding traditional medicines and OTC products in Algeria. 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 are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Traditional, herbal and complementary products are commonly regulated by Ministry of Commerce under provisions of Consumer Protection and Fraud Repression Law No 09-03 dated of 25 February 2009, published in the Official Gazette, along with the following regulations:
- Decree No 13-378 dated of 9 November 2013, published in the Official Gazette, laying down the terms and conditions related to consumer information;
- Decree No 12-203 dated of 6 May 2012, published in the Official Gazette, related to the rules applicable to product safety;
- Interministerial Decree dated of 19 October 2017, published in the Officiel Gazette, setting the terms and conditions applicable to labeling of products assimilated to foodstuffs.
However, products that contain non-food substances giving them curative or preventive properties are to be considered as drugs, and therefore are regulated as such by Ministry of Health under provisions of Health Law No 18-11 dated of 2 July 2018, published in the Official Gazette.
As per provisions of Article 210 within the Health Law No 18-11, products possessing properties useful for human health, and whose active substances are exclusively one or more herbal substances or preparations (excluding psychotropic and narcotic compounds), have an herbal-based drug status and are subject to a simplified authorization process. Exception to this rule occurs when active substances are isolated or chemically defined, in which situation chemical-based drug regulations are applicable.
Whereas presence of vitamins or minerals is not a criterion for considering a product as drug, the specified claimed indication and dietary daily reference intakes are determinant for the classification.
Besides that, monitoring of adverse reactions and/or incidents following the use of traditional, herbal or complementary products are under the scope of 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 published in the Official Gazette, which is a Ministry of Health institution.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Marketing and advertising to the public for products regulated as drugs by Ministry of Health (under provisions of Health Law No 18-11) are prohibited regardless of the channel used, but such activities are tolerated for other traditional, herbal and complementary products regulated by Ministry of Commerce (under provisions of Consumer Protection and Fraud Repression Law No 09-03) without infringement of the terms and conditions related to consumer information set in Decree No 13-378 dated of 9 November 2013.
Traditional, herbal, complementary, and alternative products were included in the Ministerial Decree No 52 dated of 10 July 1995, published in the Ministry of Health Bulletin, fixing the list of goods authorized for sale in community pharmacies. Thus, these products can directly be sold to consumers at community pharmacies, and other shops authorized by Ministry of Commerce (excluding products having the drug status, exclusively sold through authorized community pharmacies).
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
The use of any health claim is subject to the prior agreement of the Ministry of Health competent services, according to Article 23 of the Interministerial Decree of 19 October 2017, setting the terms and conditions applicable to labeling of products assimilated to foodstuffs.
Under requirements of Decree No 13-378 dated of 9 November 2013, laying down the terms and conditions related to consumer information, any representation or advertising that states or suggests that a product has particular qualities related to its origin, properties, manufacturing, composition or any other quality, shall not be misrepresented, deceptive or likely to create an erroneous impression of its nature in such a way as to mislead the consumer, and as such should not:
- be inaccurate, ambiguous, or unjustified;
- raise doubts as to the safety and/or suitability of the product;
- encourage or tolerate excessive consumption of the product;
- suggest that a balanced and varied diet cannot provide all the nutrients in sufficient quantity;
- mention changes in body functions that may inspire fear to the consumer in the form of texts, pictures or symbolic representations.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
Definition for over-the-counter (OTC) medications was introduced for the first time in the Health Law No 18-11 dated of 2 July 2018, published in the Official Gazette. They were defined as drugs that can be directly dispensed to consumers by pharmacists without prior medical prescription, and whose list is to be established by Ministry of Health.
There is no specific authorization process for OTC medications according to Health Law No 18-11, and they are assessed as drugs by Ministry of Health according to Article 230 within the same law.
5. Are there any limitations on locations or channels through which OTC products may be sold?
OTC medications can be directly sold to consumers, but only at authorized community pharmacies under pharmacist advice. According to Algerian regulations, they cannot be sold or delivered via post or other unauthorized channels.
6. What health, advertising, and marketing claims may be made for OTC products?
Under local regulations requirements, scientific information on OTC medications is mandatory (as for all authorized drugs). It must be accurate, verifiable, and in accordance with demonstrated medical data, especially for: therapeutic indications; dosage, adverse effects; contraindications; warnings, precautions for use, and drug interactions, if any. Scientific information provided is intended for health professionals and users in order to ensure the proper use of OTC medications.
Marketing and advertising of OTC medications are authorized for health professionals, but without being misleading or detrimental to the protection of public health. Advertising must present the product objectively and always promote its proper use, with respect to the provisions of the product market authorization and the therapeutic strategies recommended by the Ministry of Health.
International Nonproprietary Name (INN) has to be mentioned on internal and external packaging, as well as all scientific information, marketing and advertising supports. Each OTC product must be accompanied by a leaflet easily legible, written in Arabic and in French.
7. Can OTC products be marketed or advertised directly to the public?
According to the Health Law No 18-11 provisions, marketing and advertising for drugs to the public are prohibited regardless of the channel used. Therefore, marketing and advertising of OTC medications (included in the drug definition) are only limited to health professionals with being subject to prior technical visa of Ministry of Health which sets the list of these products.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
There is no provision within the Health Law No 18-11 for switch process of prescription-only drugs to OTC status. This mechanism shall be established in underlying regulations.
9. What are the requirements for the importation of either traditional medicines or OTC products?
Authorized importers receive an annual import permit granted by Ministry of Health for a defined list of approved products that are regulated as drugs under Health Law No 18-11 provisions. Importation must comply with technical requirements for the import of drugs and medical devices for human use set by the Ministerial Decree of 30 October 2008, published in the Official Gazette.
For products regulated by Ministry of Commerce under provisions of Consumer Protection and Fraud Repression Law No 09-03, multiyear open import license for a group of products is granted to the authorized importers. Requirements of Decree No 05-467 dated of 10 December 2005 published in the Official Gazette, setting the conditions and procedures for border control of the imported products conformity, are applicable.