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 pharmacological) and clinical trials; or
  • prove that the medicinal product is a generic medicinal product of a reference medicinal product which is or has been authorised for not less than 8 years in a EEA state or in the Community, or that the active substance(s) within the formula�� on of medicinal products in a EEA Member State is (are) widely used in medicine in the formula�� on of already registered medicinal products for at least 10 years with a recognised efficacy and acceptable safety level.

Issuing marketing authorisation

SAM decides to issue (or to refuse to issue) marketing authorisation within 210 days from receiving the application (for generic medicinal products – within 90 days). Marketing authorisation is granted for 5 years and may be renewed indefinitely.

Wholesale licence

A wholesale licence is needed for entitlement to:

  • wholesale distribution of medicinal products, active substances and excipients included in the EC list, used in manufacturing medicinal products;
  • obtain a permit for parallel import of a medicinal product;
  • bring into Latvia from another EEA state medicinal products not granted marketing authorisation.

A wholesale licence is issued according to the procedure established by law. Conditions for issue of a wholesale licence are similar to the conditions for issuing a manufacturing licence as described above.

CLINICAL TRIALS

All clinical trials, including bioavailability and bioequivalence studies, must be scientifically sound, guided by ethical principles in all aspects and planned, conducted and reported in accordance with Good Clinical Practice regulations. Clinical trials may be conducted only if the anticipated therapeutic benefit for the trial subject and other present or future patients, as well as for society at large, has been assessed and it justifies the anticipated risk. A clinical trial may be continued if conformity with this requirement is permanently monitored.

Requirements for clinical trial authorisations

Clinical trial authorisation is received in parallel by obtaining a permit from SAM and approval (positive opinion) from the Ethics Committee.

An opinion from the Ethics Committee and a permit from SAM for conducting a clinical trial requires the following information:

  • trial protocol indicating the objective, design, methodology, statistical criteria and organisation of the trial;
  • other documents and information required by law, including investigator brochure, informed consent form, as well as documents regarding civil liability insurance policy, consent of the clinical site to conduct the clinical trial, and others.

Issue of permit

The opinion from the Ethics Committee should be issued within 30 days but the permit from SAM within 60 days from receiving the application and required documents. Both authorities may request further information and thus prolong the period for issue of a decision pending receipt of supplementary information.

PROMOTION OF PHARMACEUTICAL PRODUCTS

Advertising and presents

Only advertising of non-prescription medicinal products is allowed. Advertising of medicinal products intended for the general public must include at least the name of the medicinal product, information necessary for correct use of the medicinal product, an invitation to read the package leaflet carefully and to consult with a physician or pharmacist regarding use of the medicinal product, plus a warning text on harm through unreasonable use of medical health products. Advertising where medicinal products are offered as a gift or compensation for the purchase of goods or receipt of a service, or where a gift is offered for the purchase of medicinal products, is prohibited. Distribution of medicinal products to the general public for promotional purposes is prohibited.

Advertising to medicinal specialists is subject to different rules. No material or other kind of benefit may be offered for the prescription or distribution of medicinal products, except where the benefit is to be used in the practice of medicine or pharmacy and its material value is insignificant. Latvian law does not specify what is considered a gift of insignificant material value.

Professional medical training and marketing events

If exhibitions of medicinal products, seminars, conferences, congresses, competitions and other events related to the advertising of medicinal products are organised, the event organiser must inform the Health Inspectorate not later than 7 days before the event by delivering the event programme and indicating the place and time of event activities, the organisers and sponsors of the event, participants, intended type of advertising and other information related to medicinal products, as well as the persons responsible for advertising medicinal products. Representation expenses for events with professional and scientific orientation must be subordinated to the main purpose of the event, and they must be applied only to specialists.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.