Activities

Regulatory Affairs

Advises on local requirements for each type of applications including MRP, DP, NP

  • Preparing  your MRP/DP Decentralised MAA for  new  medicinal products  and well established substances;
  • Give support acknowledging procedural timelines of EU procedures (MRP, DCP and CP);

Evaluation, advice and submition of applications to the national regulatory authority.

  • Regulatory support for marketing authorisation applications (DCP, MRP), variation applications and renewal applications in the territories defined;
  • Define national requirements (e.g. number of copies, samples, additional local documents, legalisation of documents by notary);
  • Do national translations EU-SmPC, EU-PIL, EU-packaging;
  • Complete “Core Module 1″ for submission  and  elaboration of cover letters and application forms;
  • Serve as point of contact for local health authorities;
  • Submit within the timelines defined by  and defined by procedure dossiers;
  • Forward any authority request like validation comments, deficiency letters, other comments, including translation to English where required;
  • Submit response documents provided by the MAH.

Life Cycle Management Services: variations and renewals to keep your products up-to-date., variations, renewals, provisions of regular status updates on project progress in Bulgaria.

  • Proactive management and coordination of variations, renewals ensuring scheduled timeframe;
  • Identification of potential regulatory issues;
  • Local adaptation and submission of documents.

Review CMC documentation for due diligence and gap analysis.
Review product packaging /labelling and advice on required changes.
Proof reading and local regulatory approval of artwork.

  • Support national phase submissions and negotiations with regulatory  authorities;
  • Support national phase submissions and negotiations with regulatory  authorities: proof-reading and local regulatory approval of artwork;
  • Follow up with the local regulatory authority, preparing of good quality translations where needed, packaging, artworks and SmPCs and preparing local artworks;
  • Consultants in the regulatory affairs approvall where the Bulgarian language (SmPC and PIL) is needed;
  • For CP to meet the EMEA translation timings.

Pharmacovigilance activities.

In order to receive  a marketing authorisation  and  to  placed   the market medicinal products in the European Union (EU)/Europe Economic Area (EEA),  the MAHs  are required to have a Qualified Person for Pharmacovigilance  (QPP) in place. This is a very important role with specific requirements that need to be fulfilled  pursuant to community Code 2001/83/EC  and the local Bulgarian Drug Law (LMPHM) from 13 April 2007, SG 31, Chapter  IIX,  and  the Volume 9 a of the Rules Governing Medicinal Products in Europe  and third countries.
Establishment and maintenance of the (MAH’s pharmacovigilance system (including the preparation of safety reports, receipt and processing of adverse events reports,  signal detection and risk minimisation activities and associated procedural documents;
Ongoing safety monitoring of the MAH’s marketed products and the management of emerging safety issues and concerns;
Contact person to the Bulgarian Drug Agency  for safety issues and concerns.Once an MAH receives medicinal product authorisation, the local QPP will perform roles and obligations:
Ongoing oversight of the PhV system in terms of structure and performance and to ensure appropriate preparation of relevant reports i.e.

Local Qualified Pharmacovigilance  requires a person QPP, pursuant  to  Art 187 of the Bulgarian Drug Law (LMPHM) from 13 April 2007, SG 31, where roles and responsibilities are listed involving:

  • Conduct of on-going pharmacovigilance evaluation during the post  marketing authorisation period;
  • Documenting and analysis and reports of  SUSARs, which have been known to the MAH;
  • Reports and Individual Case Safety Reports (ICSRs) in the EU and third countries need to be accessible to the local QPP;
  • Submission to the Bulgarian Drug Agency (BDA) of the expedited adverse drug reactions reports and PSURs;
  • company sponsored  Post-Authorisation Safety Study (PASS) reports;
  • Ensuring that any request  from the regulatory body are covered and provided on time;
  • Provision to the regulatory authority s with all information considered relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on post-authorisation studies and other sources.

3. Health technology assessment in Bulgaria according to the local requirements of pricing and reimbursement
4. Outcome research according to the Positive Drug List Legislation in Bulgaria
5. Clinical trial applications, amendments and closure of the procedure realted to the local authority and to the Ethic Committees

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