Traditional Medicines and OTC Products
The key facts about traditional medicines and OTC products in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
The Health Law transposed into the national legislation the provisions of Directive 2001/83/EC on the Community code relating to medicinal products for human use, and provides specific rules for the traditional herbal medicinal products and for the homeopathic medicinal products.
Traditional herbal medicinal products can be authorized by NAMMD for marketing in Romania under a simplified 120 days authorization procedure, if they meet certain conditions, such as:
- they should have adequate indications for this category of products which, due to their composition and purpose, are intended and designed for use without the supervision of a physician as to establishing a diagnosis, prescription and monitoring the treatment;
- the means of administration must be oral, external and/ or by inhalation;
- the information regarding the traditional use of the product should be sufficient, meaning that they prove that the product is not harmful under the prescribed conditions of use or that the pharmacological effects or the efficacy of the product are plausible based on its extended use and experience.
The marketing authorization for homeopathic medicinal products can also be granted by NAMMD under a simplified 120 days authorization procedure, if they meet all of the following conditions:
- the means of administration is either oral or external;
- there aren’t any specific therapeutic indications on the product’s labelling or in any information related to the respective product;
- there is a high degree of dilution to guarantee a safe use; in particular, the homeopathic medicinal product may not contain either more than one part per 10,000 of the mother tincture or more than 1% of the smallest dose used in allopathy for the active substances whose presence in an allopathic medicinal product requires a physician’s prescription.
In certain cases, the 120 days period necessary for the issuance of the marketing authorization for traditional herbal medicinal products and for the homeopathic medicinal products may be extended by NAMMD, up to 210 days.
If these type of products do not meet the legal requirement for the simplified authorization procedures, they can be authorized by NAMMD under the general authorization procedure for medicinal products.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
In principle, homeopathic and traditional herbal medicinal products can be advertised directly to the public, provided that they have a valid marketing authorization, they are not released based on medical prescription and they are not reimbursed in the social health insurance system. For certain advertisements and promotional projects, it is required to obtain the prior approval of NAMMD.
It is noteworthy that the Romanian legislation provides for various restrictions and limitations in relation to the advertising and promotion of medicinal products to the general public, which should be assessed on a case by case basis.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
In the case of traditional herbal medicinal products:
• the labelling and package leaflet should mention the product’s qualification as “traditional herbal medicine” and that: (a) the product is intended for use under the specified indications, exclusively based on its long-standing use; (b) the user should request an opinion from a physician or another healthcare professional if the symptoms persist or if any adverse reactions occur while using the product, other than the ones in the leaflet;
• all advertising materials should include the following warning: “This traditional herbal medicinal product shall be used for the specified indications, exclusively based on long-standing use.”
The labelling and package of homeopathic medicinal products leaflet should mention the product’s qualification as “homeopathic medicine” and other details, such as:
- the degree of dilution and the related symbols from the European Pharmacopeia;
- the name and address of the marketing authorization holder and manufacturer;
- the expiry date and the pharmaceutical form;
- safety precautions and warnings, as the case may be;
- the indication “homeopathic medicinal product without any prior approved therapeutic indications”;
- number of the manufacturing series; and
- a special recommendation that the user should request an opinion from a physician if the symptoms persist.
In accordance with the Health Law, advertising materials designed for the general public, including the ones concerning homeopathic and traditional herbal medicines should not suggest, amongst others, that:
- proper medical consultation or surgical intervention is not necessary, especially by offering diagnosis or long distance treatment suggestions;
- the respective medicine has a guaranteed effect and is not likely to cause adverse reactions;
- the effects are better than or equivalent to the ones of a different treatment or of another active substance, unless there is scientific evidence to support such claim;
- the patient’s overall health can only be improved by using the advertised homeopathic or herbal medicine;
- the patient’s overall health shall be affected if the product is not used.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
According to the Health Law, medicinal products can be authorized for marketing as over-the-counter (OTC) products if they do not fulfill the criteria for being qualified as products released based on medical prescription (Rx), by taking into consideration, amongst others, the following:
- the direct or indirect risks that can occur if the product is used without a physician’s supervision, even if it would be correctly administrated;
- the product’s composition, and specifically its substances or preparations thereof;
- if the product is frequently used, and if the consumers use it incorrectly, to assess if there is any direct or indirect danger for human health;
- if the product is normally prescribed by a doctor to be administered parenterally.
As opposed to the price of Rx medicinal products which is approved by the Ministry of Health, marketing authorization holders are entitled to independently set the prices of their OTC medicinal products.
However, according to the Ministry of Health’s Order no. 368/2017, the prices of OTCs prescribed and dispensed in the national health insurance system should be approved by the Ministry of Health.
Pursuant to the Pharmacy Law, pharmacies can sell OTC medicinal products online, but they are not allowed to sell prescription – only medicines online.
5. Are there any limitations on locations or channels through which OTC products may be sold?
The distribution channels are similar for Rx and OTC medicinal products, since both types of products can be sold by the manufacturers and/or the wholesale distributors to the open circuit (community) pharmacies and to the closed circuit (hospital) pharmacies, which will dispense them to the patients.
Additionally, a recent amendment of the Pharmacy Law from 2018 provided for the possibility of authorized community pharmacies to sell OTC medicines to the patients online. In order to perform online sales of medicines, the community pharmacies should submit a special notification to the Ministry of Health and create a website which should fulfill certain requirements, which should be further detailed in the near future by secondary legislation.
6. What health, advertising, and marketing claims may be made for OTC products?
According to the Health Law, the advertisements for OTC medicines should include a recommendation to carefully assess the information provided on the package or in the package leaflet, as follows: “This medicine can be released without medical prescription. Please read carefully the leaflet or the packaging information. In case of any adverse reaction, please seek the assistance of a physician or pharmacist.”
The claims used for OTC products should also comply with the general legal requirements applicable to medicinal products. If the advertising and/or promotional activities are designed for the general public, they should observe the requirements mentioned at Chapter 3 Sections 15 – 20 above.
7. Can OTC products be marketed or advertised directly to the public?
OTC medicinal products can be advertised directly to the general public, provided that general requirements on advertising medicinal products are met and the advertisement material mentions the warning formula specified in Chapter 4, Section 6, above. For certain promotional and educational materials addressed to the public, including for the information posted on internet websites, it is required to obtain the prior approval of NAMMD.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
According to the Health Law, NAMMD can approve the re-classification of a medicinal product from “subject to medical prescription” to “over-the-counter”, based on a prior assessment of any new information brought to its attention by the applicant, which would prove that the product in question does not longer meet the criteria for being qualified as Rx.
In this respect, NAMMD shall assess the criteria mentioned at Chapter 4, Section 6, above in relation to the updated situation of the concerned medicine.
Additionally, the Health Law provides that if the classification is changed based on certain significant pre-clinical tests or clinical trials, NAMMD shall not refer to the results of such tests or trials when examining a request by another applicant or marketing authorization holder for a change of classification of the same substance, for a period of 1 (one) year after the authorization of the initial change.
9. What are the requirements for the importation of either traditional medicines or OTC products?
In order to import OTC and/or other medicinal products in Romania, it is necessary to obtain an import authorization from NAMMD. To this end, the applicant should submit an application dossier with NAMMD, containing various information on the imported medicines, the import facilities and the relevant personnel, which will be verified by NAMMD during an inspection.
If the importer does not own their own warehouse, it could conclude a services agreement with a wholesale distributor which shall act as a logistic services provider.
The procedure for the issuance of the import authorization should be completed within 90 days from the filing of the complete dossier. The authorization shall specify the medicines which are imported and their manufacturers.
According to the Health Law, NAMMD should take adequate measures to ensure that the imported medicines were subject to relevant quality controls, and specifically that the batch release was performed in accordance with the requirements resulting from the marketing authorization.