Manufacturing Of Pharmaceutical Products - Latvia

Pharmaceutical products may be manufactured only by a legal entity that holds a manufacturing licence (Licence) issued by the Latvian State Agency of Medicines (SAM). The Licence authorises entire or partial production of pharmaceuticals and a variety of processes related to packaging, labelling, etc. Pharmaceutical products must be manufactured in compliance with Good Manufacturing Practice standards. The License grants the right to distribute pharmaceutical products manufactured by the Licence holder to wholesalers and import these from third countries. It is not necessary to obtain a special permit (licence) from SAM for a trader who has a special permit (licence) issued in a European Union (EU) Member State or in a state of the European Economic Area (EEA), which entitles the holder to wholesale or manufacture medicinal products.

Requirements for obtaining a Licence

A legal entity seeking to obtain a Licence must:

specify the pharmaceutical forms, the location where they will be manufactured and controlled, as well as the particular acts to be performed with medicinal products; have at its disposal sufficient and appropriate premises, technical equipment and control facilities complying with the requirements established by law; enter into a contract with a person for fulfilling the duties of a qualified person responsible for manufacture and (or) import and comply with other requirements set by law. Issue of Licence

SAM decides to issue (or justifies not issuing) a Licence within 90 days from receiving the application. The Licence is issued for an indefinite period.

ENTERING THE MARKET

Medicinal products manufactured industrially or involving an industrial process (including parallel imports of medicinal products) may be supplied to the Latvian market only if registered in the Latvian Medicinal Products Register or in the Community Register of medicinal products. Marketing authorisation for pharmaceuticals is issued by SAM. The European Commission (EC) grants marketing authorisations covering all EU Member States.

Requirements for marketing authorisation

A person seeking marketing authorisation must:

apply together with the documents and information required by law (description of the manufacturing technique, therapeutic indications, contraindications, adverse reactions, doses and route of administration etc); and provide results of pharmaceutical (physico-chemical, biological or microbiological), non-clinical (toxicological and...

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