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Information on the non-application of Sunset Clause

The procedure for not applying sunset clause is determined by Regulation No 376 of 9 May 2006, “Procedures for the Registration of Medicinal Products” (hereinafter – Regulation No 376). In accordance with Paragraph 125 of Regulation No 376 a decision of the State Agency of Medicines on registration of medicinal products shall cease to be in effect if:

  1. the medicinal products are not placed on the market of the Republic of Latvia within three years after taking of the decision on registration of the relevant medicinal products. The referred to shall not apply to the case, if at least one sales packaging of pharmaceutical form is in distribution in Latvia;
  2. the registered medicinal products, which have been previously placed on the market in the Republic of Latvia, are not actually sold for three consecutive years;
  3. the owner of registration has notified the State Agency of Medicines regarding discontinuation of distribution of the medicinal products in the Republic of Latvia;
  4. a decision on refusal of re-registration has come into effect.

However, in accordance with Paragraph 125.1 of Regulation No 376,  the Agency is entitled to take a decision not to apply the norm referred to in Sub-paragraphs 125.1 and 125.2 of this Regulation (Sunset Clause) for a period of one to three years, taking into account the application of the registration owner based on public health protection considerations (Annex 9).  

The Agency shall, within 30 days after receipt of the application referred to in Paragraph 125.1 of this Regulation, evaluate the substantiation referred to in the application in accordance with the procedures specified in the Administrative Procedure Law and take a decision on application or non-application of the norm referred to in Sub-paragraph 125.1 or 125.2 of this Regulation and inform the owner of registration thereof. The State Agency of Medicines shall publish information regarding the referred to decision on the website without delay, in the section Information regarding additional extension of marketing authorisations and non-exclusion of medicinal products (Sunset clause).

Justifications for exemption referred to in Annex 9 to Regulation No 376 are:

  1. There is lack of suitable alternative medicinal products which means that there is a potential for adverse impact on public health or the medicinal product has four or fewer analogues in the Register of Medicinal Products of the Republic of Latvia (in view of ATC codes, therapeutic alternatives, indication, route of administration);
  2. The medicinal product is a part of national reserves of medicinal products in accordance with regulatory enactments on ensuring emergency medicinal aid and anti-epidemic measures, development of medicinal product provision system and work in case of threat to state security, generic medicinal products, biological medicinal products, medicinal products that have been approved for paediatric use, orphan drugs, medicinal products intended for parenteral administration;
  3. The medicinal product is intended for certified export to non-EEA countries (third countries);
  4. The medicinal product has been mutually recognized through the mutual recognition (MR) or decentralized (DC) procedure with Latvia as RMS (to ensure supply of medicinal products in participating Member States);
  5. The medicinal product for which there is an on-going planned variation in the product registration dossier and valid marketing authorization is required to ensure patients with the medicinal product.

Marketing authorization holder or his authorized representative must submit an application to the Agency for the non-application of the Sunset Clause (the application form can be found in Annex 9 to Regulation No 376), indicating accordingly the justification for exemption.

Application form: Application in Accordance with Clause 1251 of the Cabinet of Minister’s Regulation No.376 "Medicinal Product Registration Procedure”.

 

We kindly ask you to submit the application (signed with a secure electronic signature) to the Agency by sending it via e-mail: info@zva.gov.lv

 

More information

Regulation No 376 of 9 May 2006, “Procedures for the Registration of Medicinal Products”.