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Parallel Imported Medicinal Products

Approval of Variations to Parallel Imported Medicinal Products

If, in accordance with the normative acts regarding the procedure for marketing authorisation of medicinal products, variations have been approved to the marketing authorisation documentation of a medicinal product that is authorised in Latvia and for which an authorisation for distribution of parallel imported medicinal products has been issued or an application for receipt of authorisation has been submitted, the State Agency of Medicines (SAM) will electronically inform the importer and applicant regarding approval of variations and distribution of remaining stock of medicinal products.

 

After receipt of information from SAM, the parallel importer submits an application for approval of variations, as well as follows the information provided by SAM regarding the conditions for distribution of remaining stock of medicinal products.

 

The parallel importer will discontinue distribution of a medicinal product, if the variations affect substantial sections of the marketing authorisation corresponding to type I B or type II marketing authorisation variations or are related to the expansion of marketing authorisation in accordance with the European Commission Regulation No. 1234/2008, or if the marketing authorisation has been suspended or annulled, as well as if the supply of medicinal product is prohibited and the product is withdrawn from the market.

 

The application is reviewed in accordance with the terms laid down by normative acts and the decision to approve or deny variations to parallel imported medicinal products is adopted in accordance with the terms stipulated by the Administrative Procedure Law, i.e., within one month after receipt of application at SAM.

 

The application form for variations to parallel imported medicinal products

 

 

Payment procedure

The fee for evaluation of application documentation for variations to parallel imported medicinal products is determined in accordance with Article 14, 14.1, 14.2 of the SAM paid service pricelist.

The fee for issuance of authorisation for parallel imported medicinal products, if amendments are required to the previously issued authorisation for parallel imported medicines, is determined in accordance with Article 34 of the SAM paid service pricelist, and, if the parallel importer indicates in the application that they wish to receive the authorisation in paper format, the additional fee is applied in accordance with Article 83 of the SAM paid service pricelist.

The invoice will be sent to the client’s e-mail after submission of application. Upon making payment, the invoice number and date, as well as name, surname or title of payer must be indicated in the “purpose of payment”.

 

 

Additional information

Cabinet of Ministers Regulation No. 416 of 26 June 2007 “Regarding Procedure for Distribution and Quality Control of Medicinal Products”.

Cabinet of Ministers Regulation No. 57 of 17 January 2006 “Regulations Regarding Procedure for Labelling of Medicinal Products and Requirements for Package Leaflets of Medicinal Products

 

Authorisation for Distribution of Parallel Imported Medicinal Products

Parallel import of medicinal products is the import of medicinal products authorised via national, mutual recognition and decentralised procedures from a European Economic Area country to Latvia, if these medicinal products are imported by a wholesaler that is not the manufacturer, marketing authorisation holder of these medicinal products or their legal representative who has received a permit for distribution of parallel imported medicinal products in Latvia.

 

Parallel imported medicinal products are identical to medicinal products authorised in Latvia or there are only acceptable differences stipulated by normative acts regarding the procedure for labelling of medicinal products and requirements for package leaflets of medicinal products.

 

The application for issuance of authorisation for distribution of medicinal products is reviewed in accordance with the terms laid down by normative acts (i.e., within 5 working days) from receipt of application and the decision to issue or deny authorisation for distribution of parallel imported medicinal products is adopted within the terms stipulated by the Administrative Procedure Law, that is, within one month after receipt of application at the State Agency of Medicines (SAM).

 

The authorisation is issued as an electronic document within 3 working days following adoption of decision regarding issuance of authorisation and after the parallel importer has paid the fee for evaluation of documentation.

The authorisation in paper format is issued for an additional fee within 3 working days after receipt of request.

 

The application for authorisation for distribution of parallel imported medicinal products

 

 

Payment procedure

The fee for evaluation of application documentation for receipt of authorisation for distribution of parallel imported medicinal products is determined in accordance with Article 14 of the SAM paid service pricelist.

The fee for issuance of authorisation for distribution of parallel imported medicinal products is determined in accordance with Article 34 of the SAM paid service pricelist, and, if the parallel importer indicates in the application that they wish to receive the authorisation in paper format, the additional fee is applied in accordance with Article 83 of the SAM paid service pricelist.

The invoice will be sent to the client’s e-mail after submission of application and prior to issuance of authorisation. Upon making payment, the invoice number and date, as well as name, surname or title of payer must be indicated in the “purpose of payment”.

 

Please note

Together with the application for issuance of authorisation for distribution of parallel imported medicinal products in Latvia, the parallel importer of medicinal products must submit information in writing and in electronic format regarding the retail price of the relevant medicinal products in Latvia (for each pharmaceutical form depending on amount of active substance per unit of product and number of units per packaging) without the value added tax.

 

After receipt of authorisation

After receipt of authorisation for distribution of parallel imported medicinal products, in accordance with the normative acts the parallel importer must submit in writing to SAM a notification regarding the actual date for initiation of distribution (marketing) of medicinal product in Latvia and regarding the date of temporary or permanent discontinuation of medicinal product distribution in Latvia, indicating the product number in the Medicinal Product Register of Latvia for parallel imported medicinal products.

 

The parallel importer must also follow the changes applicable to the medicinal products authorised in the member state indicated as the member state of origin in the application for authorisation for distribution of parallel imported medicinal products and must inform SAM regarding changes affecting the medicinal product and conditions for distribution of remaining stock of medicinal product.                   

 

 

Additional information

Cabinet of Ministers Regulation No. 416 of 26 June 2007 “Regarding Procedure for Distribution and Quality Control of Medicinal Products

Cabinet of Ministers Regulation No. 57 of 17 January 2006 “Regulations Regarding Procedure for Labelling of Medicinal Products and Requirements for Package Leaflets of Medicinal Products

Cabinet of Ministers Regulation No. 803 of 25 October 2005 “Regulations Regarding Principles for the Determination of the Price of Medicinal Products