With the Bulgarian Drug Law amendments published on 21-Dec-2012 a new obligation was imposed concerning all marketing authorisation holders (MAHs) in Bulgaria. Based on article 104, paragraph 4 of Directive 2001/83/EC as amended by Directive 2010/84/EU, Bulgaria has opted to implement obligation for the MAHs to appoint a local contact person for pharmacovigilance issues (LPPV) at national level reporting to the QPPV.
Article 191, paragraph 3 of the Bulgarian Law on Medicinal Products in Human Medicine imposes the following obligation: The marketing authorisation holder shall appoint a person established on the territory of the Republic of Bulgaria in order to assist the activities of the qualified person. The appointing of such a person shall not relieve the qualified person of his/her responsibilities. The text does not include any specific provisions concerning the medicinal product’s authorisation procedure (e.g. nationally authorised drugs or drugs under centralised procedure).
The scope of activities of the LPPV depends on the pharmacovigilance setup of the MAH as the legislation does not set any specific requirements to the supportive role of the LPPV. The specific point is that the appointment of the LPPV has to be submitted to the Bulgarian Drug Agency by the MAH. Changes of the LPPV details are not considered as variation.
On 21-Feb-2013 the Bulgarian Drug Agency posted a notification on their website that the deadline for the existing MAHs to appoint their LPPV for Bulgaria is 31-Mar-2013.
Additional sources of information (section updated March 2018):
EMA: Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level
CMDh: Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures
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