Traditional Medicines and OTC Products
The low-down on the situation regarding traditional medicines and OTC products in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
The Medicinal Products Act contains special regulations governing Traditional Herbal Medicines and Homoeopathic Medicinal Products:
1. As per secc. 39a et seqq. of the Medicinal Products Act, Herbal Medicinal Products may be brought into market circulation as “Traditional Herbal Medicines” (i.e. herbal medicinal products the effectiveness of which is solely documented by their long-standing traditional use), provided the product has been registered as such with the competent federal authority, namely the Federal Agency for Medicinal Products and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). In this case, no additional market authorization of § 25 of the Medicinal Products Act is required. Of course, a herbal medicinal product can also be marketed based on a regular market authorization, but in this case it may not be called “Traditional Herbal Medicine” and it cannot be registered as such. In the registration procedure, it must be shown that the Traditional Herbal Medicine has traditionally been in use for at least 30 years, at least 15 of which in the EU, that the product does not have harmful effects, and that the pharmacological effects of the product are plausible based on the long-term experience and use of the product.
2. Homoeopathic Medicinal Products must be registered with the BfArM instead of obtaining a regular market authorization in order for the Homeopathic Medicinal Product to be marketable as such (see secc. 39 et seq. of the Medicinal Products Act, also listing the possible reasons for refusal of registration). Like in the case of Traditional Herbal Medicines, an existing market authorization hinders a registration of the Homoeopathic Medicinal Product as such. The market authorization can be waived by its holder, though.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
In general, advertising for such medicinal products is subject to the same legal provisions (in particular as set forth in the Health Advertising Law) like advertising for regular medicinal products (for details, see the answer to question 38 above). Advertisements for traditional herbal medicines must include the statement “Traditional herbal medicine to be applied for [specific field of application] exclusively based on long-time application” (§ 4 par. 1 sentence 2 of the Health Advertising Law), whereas advertisements for homoeopathic medicinal products may not contain an indication of the field of application (§ 5 of the Health Advertising Law).
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
See the answers to questions 45 and 38 above.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
Concerning the authorization process, see the answer to question 22, regarding pricing, see the answer to question 12 above.
5. Are there any limitations on locations or channels through which OTC products may be sold?
1. Non-prescription medicinal products can be further sub-classified as pharmacy-only or general-sale products. Most medicinal products and some medical devices may only be sold in pharmacies; this is the general rule for medicinal products set forth in § 43 of the Medicinal Products Act (see answers to question 14 and 39/49 above).
2. Exceptions from this rule can be found in §§ 44 et seqq. of the Medicinal Products Act and in the Ordinance on Pharmacy-Only and General-Sale Products (Verordnung über apothekenpflichtige und freiverkäufliche Arzneimittel (AMVerkRV) of 24. November 1988, most recent amendment of 26. September 2018).
3. Regarding medical devices, details on their classification as prescription-only and pharmacy-only products are set forth in the Ordinance on the Dispensing of Medical Devices (Verordnung zur Regelung der Abgabe von Medizinprodukten (Medizinprodukte-Abgabeverordnung – MPAV), dated 25 July 2014, most recent amendment of 21 September 2018.
4. If a medicinal product is classified as a general-sale product, it still may not be sold through vending machines or other self-service sale channels but only through shops where at least one qualified person is available to give advice. The aforementioned restrictions do not apply to very few, very specific products like plant parts, plant juices, curative waters, contraceptives, medicinal products designated to prevent sexually transmitted diseases, disinfectants for outward application, or oxygen (see secc. 50 et seqq. of the Medicinal Products Act).
6. What health, advertising, and marketing claims may be made for OTC products?
Advertising of OTC medicinal products is governed by specific provisions in the Health Advertising Law (for further details, see the answer to question 38 above). OTC products which are a prescription-only medicinal product may not be advertised to the general public but to members of the medical professions and medic trade, only (sec 10 of the Health Advertising Law).
7. Can OTC products be marketed or advertised directly to the public?
Yes, provided the applicable restrictions (in particular those set forth in the Health Advertising Law and the Unfair Competition Act) are observed.
Advertising to the general public is not permitted for prescription medicinal products. For details, see the answers to questions 49 and 38 above.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
1. In general, such conversion is not possible unless the composition of the medicinal product is changed and a new market license is obtained. The question of whether a product is classified as a prescription-only product depends on the active pharmaceutical ingredients used in the product. The mere presence of certain active substances listed in the Ordinance on Prescription Drugs (Verordnung über die Verschreibungspflicht von Arzneimitteln, (Arzneimittelverschreibungsverordnung – AMVV) of 21. December 2005, most recently amended on 26. September 2018), or the use of substances the effects of which are not commonly known in medical science (§ 48 par. 1 no. 3 of the Medicinal Products Act) results in the product’s classification as prescription-only drug.
2. Exeptions apply in case the relevant active substance is used in a homoeopathic dose (§ 5 of the Ordinance on Prescriptive Drugs). In certain special cases (such as with medicinal products intended for animal use if the animal is raised for food production (see § 48 par. 1 no. 2 of the Medicinal Products Act), a specific indication or purpose of the product can result in a prescription-only classification. If that purpose falls away, the prescription-only classification may fall away as well. However, it is mandatory in all of these cases that a new market authorization and classification is obtained.
9. What are the requirements for the importation of either traditional medicines or OTC products?
Importation regulations for traditional herbal medicines, OTC medicinal products and prescription drugs are essentially similar. In a nutshell, the importation of medicinal products generally requires a valid market authorization or product registration for Germany. In addition, pursuant to § 73 par. 1 of the Medicinal Products Act, if the medicinal product is imported from an EU or EEA member state, the (professional) recipient in Germany must be a licensed pharmaceutical business, a wholesaler or a veterinarian, or it must run a pharmacy or a hospital. If the medicinal product is imported from a country outside the EU and the EEA, the recepient must be a holder of an importation license according to secc. 72, 72b or 72c of the Medicinal Products Act. If the medicinal product is sent directly to a consumer from abroad, the sender must be an EU or EEA based pharmacy holding a permission to perform mail-order trade with medicinal products according to § 11a of the Pharmacy Law, or according to the equivalent national law of the EU or EEA member state where the sender is seated, provided the German regulations on mail-order trade with medicinal products (in particular, §17 par. 2a and par. 2b of the Ordinance on the Operation of Pharmacies (Verordnung über den Betrieb von Apotheken (Apothekenbetriebsordnung – ApBetrO) of 09 February1987, most recent amendment of 2 July 2018) are observed.