Manufacturing and distribution of medicinal products in Latvia is permitted only if a special permit (licence) has been received for the relevant type of business.
Company which has received a special permit (licence) in a European Union (EU) Member State or European Economic Area (EEA) State, which ensures the right to perform wholesale or manufacturing of medicinal products, has a duty to provide the State Agency of Medicines (SAM) with the information specified in the regulatory enactments on the distribution of medicinal products in Latvia regarding the commencement of wholesale of medicinal products. In such case, a merchant (wholesaler) does not need to receive a special permit (licence).
Company established in an EU Member State or EEA State to which a special permit (licence) for wholesale of medicinal products has been issued in the home country, should submit an application in free form to SAM (application can be submitted on site, by post (address: Jersikas iela 15, Riga, LV-1003) or sending an e-signed application to an e-mail address email@example.com). The application should specify the following basic information:
- the type, date and number of the special authorisation (licence) granted in the EU Member State or EEA State and information about the competent national authority which has issued the special authorisation (licence);
- a copy of the licence issued in an EU Member State or EEA State and a translation thereof;
- foreign merchants branch firm, registration number in the Register of Enterprises of the Republic of Latvia, legal and business location address, telephone and fax number, e-mail address;
- the given name, surname of the official responsible person for good distribution practices (which is the pharmacist or the qualifications and experience of which are similar to the qualification of the qualification person, as specified in the regulatory enactments of Republic of Latvia regarding the manufacturing and quality control of medicinal products), the actual address of the workplace, telephone and fax number and other means of communication;
- the list of official responsible persons to be contacted in the event of the withdrawal of defective medicinal products;
- a list of instructions and an alarm plan containing information on the withdrawal of medicinal products from the stocks to be sold, the return of medicinal products, the withdrawal of medicinal products from the market.
Upon receipt of the documents, the SAM will verify the information submitted and, if necessary, request additional information from the competent authority of the applicant and/or the applicant's home country.
A decision on the recognition of a licence will be taken within the time limits specified in the Administrative Procedure Law (30 to 120 days since the submission of documents to SAM), the information regarding it being published on the website of the SAM.
Companies branch office may only commence wholesale sale of medicinal products in Latvia following a positive decision of the SAM (authorisation).
In accordance with Section 17 of the Pharmaceutical Law, only medicinal products authorised in Latvia and included in the Latvian Register of Medicinal Products or the Latvian Register of Veterinary Medicinal Products are permitted to be distributed, except for the cases referred to in Section 10(7), Section 12(7) and (10) and Section 20 of this Law. Medicinal products authorised in the centralised marketing authorisation procedure in the European Medicines Agency may be distributed without authorisation of such medicinal products in national marketing authorisation procedures.
A branch of a foreign merchant established in an EU Member State or EEA State must submit to SAM the sales data of the medicinal products for each month by the 15th day of the following month, annually (until 31 January of the following year), the amount of medicinal products (including supplies from the EEA and to the EEA State). The data should be submitted electronically using the SAM Information System (SAMIS) Statistical Module of the Consumption of Medicines. The SAMIS database can be used, if the company has signed the mutual agreement with SAM. In order to sign the agreement an application must be submitted to SAM (Cabinet No. 416, Paragraph 18, 19).
In addition, please be informed that wholesalers of medicinal products, who distribute medicinal products in Latvia in accordance with a licence issued in an EU Member State or EEA State, are the subject to the requirements of Cabinet Regulation No. 416 of 26 June 2007, Procedures Regarding the Distribution and Quality Control of Medicinal Products, as well as other regulatory enactments regulating the pharmaceutical industry.