Traditional Medicines and OTC Products
A brief overview of the situation regarding traditional medicines and OTC products in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
The regulatory requirements for traditional and herbal products shall follow the regulations and standards:
- WHO requirements and guidelines;
- Good Manufacturing Practices;
- Good Laboratory Practice;
- Good Pharmacovigilance Practice;
- Good Agricultural and Collection Practices;
- Good Pharmacovigilance Practice for Arab countries; and
- Ministry of Health’s regulations, instructions, laws and internal regulations.
Moreover, in order to obtain the registration of the Traditional and Herbal products, a separate application is required for each product. Applications shall be made by submitting a completely filled in application form which shall be accompanied with:
- Complete documentation as per these guidelines. (All ingredients must comply with specification prescribed in Pharmacopoeias. In-house specification may be acceptable if justified by validation reports).
- For under license products, original notarized Certificate of Pharmaceutical Product from the Drug Regulatory Authority of the country of origin of the product should be submitted. This shall be accompanied with approved product information.
- Copy of license of the manufacturing site for local manufacturers and toll register for toll manufacturers.
- Pilot samples of each package size being applied for registration (One commercial sample for re-registration if required in case of variation) to carry out quality control tests as declared in the dossier. The samples must be in the form and container in which they will be marketed.
- Stability study should be done on pilot batch(es) on the finished product in its final container closure system as accelerated (6 months). (In case of re-registration, the stability study is done on at least one production batch in the final container closure system as accelerated stability study (6 months) or long-term stability study).
- Pharmacovigilance requirements for herbal medicinal products.
- Patient Information Leaflet draft and Artwork (Mock-ups)
- An appropriate and complete index/ list of the various sections and documents of submission.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Advertising any pharmaceutical product whether herbal or complementary or alternative products shall be obtaining an approval of advertising the product and must approve on the pamphlet information of the product from technical committee in the Ministry of Health before publishing the products to the public.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
Over the counter (non-prescription), medicines are regulated by Ministerial Decree No. 422 of the year 2014, which promulgates that non-prescription medicines are determined in a list, which is issued by the Ministry of Health to the public.
5. Are there any limitations on locations or channels through which OTC products may be sold?
6. What health, advertising, and marketing claims may be made for OTC products?
7. Can OTC products be marketed or advertised directly to the public?
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
9. What are the requirements for the importation of either traditional medicines or OTC products?