Medical Affairs

Assistance in acquiring authorizations for distribution of parallel imported medicinal products in Latvia

A parallel imported medicinal product may be distributed under a licence obtained through a simpler procedure than that for the initial marketing authorization for the product, provided that the parallel sales do not pose a risk to public health. According to the EU Commission, this simplified procedure for parallel imports is justified by the fact that the product in question has already received a marketing authorization on the basis of full technical information.

To qualify for the simplified procedure, the parallel imported medicinal product must satisfy two conditions. It must:

  • have been granted a marketing authorization in the Member State of origin; and
  • be sufficiently similar to a product that has already received marketing authorisation in the Member State of destination.

The similarity between two pharmaceutical products is considered to be sufficient when the two products have been manufactured according to the same formulation, using the same active ingredient, and have the same therapeutic effects. A parallel imported medicinal product can also be distributed under the simplified procedure even if the similar product upon which its licence is based is no longer available on the market, provided that public health requirements are met (source- Europa.eu/summaries of EU legislation).

„Medlex Baltics” will consult you and work as your authorized representative in Latvia for registration of parallel imported medical products in the State Agency of Medicines and of food supplements in Food and Veterinary Service.

Registration of parallel imported medicinal products in Latvia

 

Parallel import of medical products is delivery of medicinal products registered under national registration procedure ( also under mutual recognition procedure and decentralized procedure) from one European Economic Area country to Latvia, under condition if being delivered by the wholesaler of medicinal products who is not a manufacturer of these products, marketing authorization holder or their authorized representative.

(Regulations of the Cabinet of Ministers No.416, [6])

 

In order to register parallel imported medicinal products in the State Agency of Medicines and to receive an authorization for distribution, the wholesaler of medicinal products shall perform a range of procedures and activities, including drawing up respective documentation, packaging layout and product information leaflet and the verification of the sample against the newest registered information in the competent institution of the respective EU country of origin of the medicinal product sample.

The competent and experienced team of Medlex Baltics:

  • Will consult you on the parallel imported products, legislation, problems and risks that the importer is more often exposed to;
  • Will verify the samples of the parallel  imported products against the actual information registered in the competent institution of the respective country of the European Economic Area;
  • Will prepare the documentation for the receipt of the authorization of distribution of the parallel imported medicinal product in the Republic of Latvia;
  • Will prepare and consult you on the layout of the primary and secondary packaging and the product information leaflet of the medicinal product for the parallel imported medicines to be distributed in Latvia;
  • Will prepare translations of the product information leaflets and packagings of your parallel imported medicinal products from Bulgarian, Romanian, Spanish, French, Russian, English, Polish, Greek, Dutch, Danish and other languages into Latvian language;
  • Will act as your authorized representative in the State Agency of Medicines regarding the receipt of authorizations for distribution of the parallel imported medicinal products, to perform amendments in the application documentation, packaging layouts, and other issues related to receipt of authorizations for distribution of parallel imported products.
  • Will prepare notifications to the Marketing Authorization Holder and Trademark Authorization Holder regarding the intention to commence parallel import of the respective medicinal products ( in certain cases Trademark authorization holder may ask to the wholesaler performing the parallel import to send a sample of the repacked  medicinal product, if the medicinal product is planned to undergo repackaging process in Latvia).
  • Will perform other activities related and necessary for the receipt of authorization for distribution of the parallel imported medicinal products in the Republic of Latvia.

Legislative acts regulating the procedure of distribution of medicinal products in the Republic of Latvia:

Cabinet Regulation No. 416 – Procedures Regarding the Distribution and Quality Control of Medicinal Products

Cabinet Regulation No. 57 – Regulations Regarding Procedures for the Labelling of Medicinal Products and the Requirements to be set for Package Leaflets of Medicinal Products

Registration of food supplements marketed in the European Economic Area:

Cabinet Regulation No. 725 – Regulations regarding the Mandatory Harmlessness and Labelling Requirements for Food Supplements and the Procedures for Registration of Food Supplements