April 9, 2019
Information on the national level contact person regarding pharmacovigilance issues
Considering the enquires the State Agency of Medicines of Latvia has received on the national level contact person regarding pharmacovigilance issues stated in paragraph 15.4 of the Cabinet of Ministers Regulation No. 47 “Procedure for Pharmacovigilance” please be informed of the following explanation.
Article 11, Point 1(e) and 1(g) of the 19th June 2012 Commission Implementing Regulation (EU) No. 520/2012 regarding the performance of pharmacovigilance activities determined by Regulation (EC) No. 726/2004 of the European Parliament and of the Council and Directive No. 2001/83/EC of the European Parliament and of the Council states that the marketing authorisation holder shall effectively communicate with the competent State institutions and the European Medicines Agency, including communication regarding new or changed risks, pharmacovigilance system master file, risk management systems, risk minimisation measures, periodic safety update reports, corrective and preventive measures and post-authorisation studies, and shall appropriately provide relevant safety information to healthcare professionals and patients.
In accordance with Point 15.3 of 22nd January 2013 Cabinet of Ministers Regulation No. 47 “Procedure for Pharmacovigilance” (hereinafter - Regulation) the marketing authorisation holder shall constantly and continuously employ a responsible Qualified Person who lives and works within the European Union and is responsible for the development and maintenance of a pharmacovigilance system. In accordance with Point 15.4 of this Regulation the marketing authorisation holder shall appoint a national level contact person regarding pharmacovigilance issues, if the responsible person does not live and work in Latvia. The contact information or changes in the contact information (if any) of the national level contact person shall be immediately submitted to the State Agency of Medicines.
The Regulation states that the Qualified Person responsible for pharmacovigilance shall live and work within the European Union. At the same time the marketing authorisation holder shall ensure effective and appropriate communication with agencies, patients and healthcare professionals on a national level. Taking into account the aforementioned information, the national level contact person should have thorough knowledge of the State language to ensure effective and appropriate communication.
May 18, 2018
Subgroup of common visual reminder (boxed warning and pictogram) to warn patient about teratogenic or foetotoxic effect on Baltic Package agreed upon the following common pictogram and its layout
For medicinal products where a visual reminder on the outer package to warn patient about teratogenic or foetotoxic effect has been requested as part of additional risk minimisation measure, the pictogram and the boxed warning must be placed on a dedicated surface of the outer packaging bearing no other labelling. Text in boxed warning must contain same languages as on the labelling.
Boxed warning and pictogram must be placed side by side.
The pictogram must take the form of a red triangle on a white background, at least a centimetre in diameter, containing an image of a pregnant woman in black. The dimensions of the pictogram, which must be legible, shall be adapted to the size of the outer packaging of the medicinal product. The use of common pictogram has been agreed by Estonian, Latvian and Lithuanian agencies.
In order to ensure a harmonised risk communication for patients in Latvia, the State Agency of Medicines invites all Marketing authorisation holders of the relevant medicinal products registered in national, decentralised and mutual recognition procedures to use the same visual reminder as recommended for the Baltic Package on the outer packaging of their represented medicinal products.