Various products related to the improvement of human health can be categorised according to the currently applied classification groups – medicinal products, medical devices, foodstuffs, food supplements, dietic foods, cosmetics, biocides, etc., whose assessment and control of distribution are regulated by specific normative acts and different competent authorities.
In order to provide an opinion on whether a product (e.g. food supplement, cosmetic, biocide, medical device etc.) meets the definition of a medicinal product under the Pharmaceutical Law, as required by Cabinet of Ministers Regulation No 376 of 9 May 2006 “Procedures for the Registration of Medicinal Products”, the State Agency of Medicines (hereinafter – SAM), together with the relevant competent authorities and independent experts, carries out a product evaluation.
The Commission on Evaluation of Product Compliance with the Definition of Medicinal Products (hereinafter – the Commission) was established in 2007 and is involved in product evaluation, and includes representatives of the Health Inspectorate, LLC “Certification Centre of Latvia” and the Food Surveillance Department of the Food and Veterinary Service.
The rules of procedure of the Commission and information on the members of the Commission are published on the SAM website.
Request for an opinion and documents to be submitted
To obtain an opinion on whether a product meets the definition of a medicinal product, you must submit an application (download the application form) to the State Agency of Medicines, together with the documents and data listed in Article 127 of the Cabinet Regulation No 376 “Procedures for the Registration of Medicinal Products”:
- Name of the manufacturer and distributor, registration number in the Enterprise Register and address of the manufacturer and distributor(s);
- Product name, ingredients and their quantity(ies) in mass units or volume units per packaging unit;
- Normative technical documents approved by the manufacturer or the product description, including the product characteristics, composition, specific ingredients and their quantity;
- Recommended daily dose;
- Type and size of packaging;
- Labelling text;
- Specimen package leaflet/ instructions for use;
- Other informative material relating to the product under assessment.
Options for submission of documents
Documents may be submitted electronically by e-mail to email@example.com or to the SAM e-address, provided that the documents are signed with a secure electronic signature containing the text “Product compliance with the definition of a medicinal product” and the product name in the subject line.
Information on secure electronic signatures is available here.
Sending documents to the e-address of the State Agency of Medicines does not confer any legal effect on the document, but only guarantees its delivery. Documents sent to SAM e-address must be signed with a secure electronic signature in the same way as if the documents were sent by other means, e.g. e-mail.
If the above-mentioned documents are not prepared in accordance with the requirements of normative acts on electronic documents, they must be submitted in paper form to Customer Service Centre of SAM (room 11, address: Jersikas iela 15, Riga, LV-1003) and the electronic version of these documents must be sent to the e-mail address firstname.lastname@example.org with the text “Product compliance with the definition of a medicinal product” and the name of the product in the subject line and a confirmation in the body of the e-mail that the electronically submitted documents are identical to the documents submitted to SAM in paper form.
Each product is evaluated on an individual basis, based on the relevant legislation, the latest scientific literature and other available information. Relevant decisions of the Court of Justice of the European Union are also taken into account.
In assessing the characteristics of the product, particular attention is paid to:
- The qualitative and quantitative composition of the product;
- The pharmacological, immunological and metabolic properties of the product, in so far as they can be determined in the light of current scientific knowledge;
- The route and method of administration and whether a product of similar composition has been registered as a medicinal product;
- Recognition of the product by consumers;
- The risks which may arise from the use of the product;
- Information on the product (labelling, instructions for use, promotional material and other information).
Advance payment for this service must be made in full in accordance with the price list of the State Agency of Medicines (Article 9) – in the amount of EUR 650.00.
Upon receipt of the application, SAM will send an invoice for the advance payment to the e-mail address provided in the application. When making the advance payment, you must include the invoice number and date in the payment order.
After issuing the opinion, SAM will send an invoice to the e-mail address provided in the application as confirmation of the services provided.
Zāļu valsts aģentūra
Jersikas iela 15, Rīga LV-1003
VAT reg. No. LV90001836181
BIC TRELLV 22XXX
Providing an opinion
The State Agency of Medicines will issue an opinion on whether the product meets the definition of a medicinal product within two months of the submission of the application and receipt of the advance payment, excluding the time required to receive additional information.
SAM will provide the opinion on the compliance of the product with the definition of a medicinal product, as laid down in the Pharmaceutical Law, in electronic format by sending it to the e-mail address indicated in the application. If the applicant wishes to receive the opinion in paper format, he/she should inform SAM and SAM will send the opinion within five days of the provision of the opinion to the legal address indicated in the application or, if the applicant has indicated a different address for correspondence, to the address indicated by the applicant.
If the product is found not to meet the definition of a medicinal product, SAM will not determine the category into which the product falls.
If the product is found to meet the definition of a medicinal product, it may only be marketed after registration with SAM in accordance with the requirements for medicinal products set out in the relevant normative acts.