Responsibilities of the MAH of pharmaceutical product

The marketing authorisation holder of a medicinal product shall:

- Ensure the establishment of a pharmacovigilance system and quality system in accordance with the system referred to in Paragraph 4 of this Regulation. The quality system shall be developed in accordance with Article 8 of Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/EC of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (hereinafter - Regulation No 520/2012);

-Using the pharmacovigilance system referred to in the Sub-paragraph 15.1 of this Regulation, perform a scientific evaluation of the information, and, if necessary, implement appropriate risk minimisation measures;

- Have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance (hereinafter - the responsible person) who is living and working in the European Union and is responsible for the establishment and maintenance of the pharmacovigilance system. The given name, surname, address of the site of operation, electronic mail address, telephone number, and fax number (if any) of the responsible person, including for communication outside working hours, shall be submitted to the State Agency of Medicines, as well as to the European Medicines Agency in the format which is used for electronic submission of information to the European Medicines Agency regarding all medicinal products for human use authorised in the European Union;

- Appoint a national level contact person for pharmacovigilance issues (hereinafter - the national level contact person) who lives and works in Latvia, if the responsible person does not live and work in Latvia. The contact details of the national level contact person - the given name, surname, address of the site of operation, electronic mail address, telephone number, and fax number (if any), including for communication outside working hours, as well as changes in the contact details (if any) shall be submitted to the State Agency of Medicines without delay;

- Maintain and, upon a request of the European Medicines Agency or the State Agency of Medicines, ensure availability of the copy of the pharmacovigilance system master file within seven days;

- Ensure that the risk management system has been established and is functioning with respect to all medicinal products, except for those with a marketing authorisation granted before 21 July 2012, unless otherwise provided for in the laws and regulations regarding the marketing authorisation procedures;

- Monitor the results of the risk minimisation measures included in the risk management plan or determined in accordance with the laws and regulations regarding the marketing authorisation procedures;

- Regularly update the risk management system and monitor pharmacovigilance data to determine, whether new risks have arisen, risks have changed or there are changes in the risk-benefit balance of the medicinal product. The risk minimisation measures drawn up for the medicinal product shall be submitted to the State Agency of Medicines for co-ordination;

- Perform a regular audit of the pharmacovigilance system, place a note concerning the main discrepancies found during the audits in the pharmacovigilance system master file, and ensure that an appropriate corrective action plan is prepared and implemented on the basis of the audit.

The national level contact person shall report to the responsible person on pharmacovigilance activities and act according to the instructions of the responsible person. With respect to the collection, recording, reporting and assessment of pharmacovigilance data, the marketing authorisation holder of the medicinal product shall:

- Record all serious suspected adverse drug reactions observed in any EEA state or in any third country which are brought to its attention from the report of a medical practitioner, pharmacist or patient, or occurring in the context of a post-authorisation study, and immediately, but no later than within 15 days after receipt of the information, shall send the report electronically for submission to the European Union adverse reactions database (hereinafter - the Eudravigilance database);

- Record all non-serious suspected adverse drug reactions observed in any EEA state, and shall send the report electronically for submission to the Eudravigilance database no later than within 90 days after receipt of the information; Ensure availability of the reports referred to in Sub-paragraphs 17.1 and 17.2 of this Regulation at the Eudravigilance database;

- Accept and examine the reports provided by the State Agency of Medicines, medical practitioners, pharmacists, including if they are forwarded by a parallel importer and parallel distributor, and patients on the suspected adverse drug reactions;

- Draw up written procedures for the collection of precise and verifiable data for the scientific evaluation of the report on suspected adverse drug reactions, and also additional information regarding the report on suspected adverse drug reactions;

- Co-operate with the European Medicines Agency and competent authorities of the EEA states to identify duplication of reports on suspected adverse drug reactions;

- Electronically submit to the European Medicines Agency periodic safety update reports (hereinafter - the periodic reports) in accordance with Chapter V of this Regulation;

- Submit an application to the State Agency of Medicines for variation to the marketing authorisation of the medicinal product, appending an updated summary of product characteristics and patient information leaflet in accordance with the laws and regulations regarding the procedures for the marketing authorisation of medicinal products;

- Inform the European Medicines Agency and the State Agency of Medicines if any new risks have arisen, the existing risks have changed, or changes in the risk-benefit balance have been identified;

- After receipt of information regarding serious suspected adverse drug reactions which are brought to attention, as soon as possible, but not later than within 15 days, inform the State Agency of Medicines.

Prior to making a public announcement, the marketing authorisation holder shall inform the State Agency of Medicines, the European Medicines Agency and the European Commission on the safety of the authorised medicinal product. The marketing authorisation holder shall ensure that the provided information is objective, it may not be misleading. Suspected adverse drug reactions established during the clinical trials shall be recorded in accordance with the laws and regulations regarding the procedures for conducting clinical trials and observations on the use of medicinal products.