26 Aug Effective Regulatory Affairs Consultancy through Collaborative Project Management

Posted at 17:51h in Regulatory Affairs

In the dynamic world of pharmaceuticals, regulatory affairs (RA) play a critical role in ensuring that products meet all necessary legal and safety requirements before reaching the market. However, with the complexity of regulations and the ever-changing global landscape, RA departments are facing increasing challenges....

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22 May New disposal claim for medicines in Romania

Posted at 13:14h in Regulatory Affairs

On May 20, 2024 the Romanian Drug Agency posted an announcement about the necessity to amend the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) regarding the waste management of unused and/or expired medicines from the population, as follows: Annex 1 (PIL) to...

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08 Apr Simplify your promotional materials approval process

Posted at 11:44h in Problem-Solution, Regulatory Affairs

Have you ever struggled with the local adaptation and approval/notification of promo materials for medicinal products? If yes, then you know it could be challenging and you might be interested to see our successful experience with promotional materials in Bulgaria. The legal provisions that contain guidelines...

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11 Mar Why do you need local regulatory intelligence in pharma sector?

Posted at 10:00h in Legislation, Problem-Solution, Regulatory Affairs

Regulatory Intelligence, as a systematic approach, includes the processes of regularly and proactively collecting regulatory information and analysing the latest updates that impact the operations of an organization. Regulatory Intelligence helps companies cope with the dynamics in regulations, accommodate changes, and ensure compliance. On February 23,...

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21 Feb Transfer of Marketing Authorisation: What you should know for Bulgaria?

Posted at 12:34h in Problem-Solution, Regulatory Affairs

A Transfer of Marketing Authorisation (MA) is the formal process for medicinal products through which the MA shifts from the current approved Marketing Authorisation Holder (MAH) to a new MAH, which is a distinct legal entity. This transfer may be prompted by a strategic decision...

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05 Feb How do you ensure RA continuity during a well-deserved break, maternity, or long sick leaves?

Posted at 14:51h in Problem-Solution, Regulatory Affairs

In the fast-paced world and dynamic environment of a Pharma Company where critical business processes demand constant attention, the Regulatory Affairs (RA) Managers often find themselves facing a dilemma, especially in the holidays season, but not only...

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31 Oct Investing in Excellence: Comprehensive Training on EU Registration Procedures and eCTD Submissions at PharmDedict

Posted at 19:47h in Regulatory Affairs

At PharmDedict, we firmly believe in nurturing our team's talents to achieve excellence. We understand that our people are critical to our success, and that's why we're committed to finding, engaging, and growing the best talent. With a strong focus on local expertise, we recognize...

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02 Jul The Bulgarian Drug Agency officially joined the PIC/S

Posted at 09:41h in GMP/GDP, Regulatory Affairs

The Bulgarian Drug Agency (BDA) officially joined the PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme as its 55th Participating Authority, effective from July 1, 2023. PIC/S is a non-binding co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of...

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14 Aug Changes at the Romanian Drug Agency

Posted at 19:01h in Legislation, Regulatory Affairs

In July 2019, the National Agency for Medicines and Medical Devices (NAMMD) was reorganised and changed its name to National Agency for Medicines and Medical Devices of Romania (NAMMDR). This change needs to be considered in relation to the communication with the Agency and, more...

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27 Feb Bulgaria: managing alerts during verification and decommissioning of medicines

Posted at 16:48h in GMP/GDP, Legislation, Regulatory Affairs

After February 9th 2019 the EU drug verification system (established by the Falsified Medicines Directive (Directive 2011/62/EU) and further detailed by Commission Delegated Regulation (EU) 2016/161) became applicable. The Bulgarian Drug Agency (BDA) and the Bulgarian Medicines Verification Organisation (BGMVO) published the first Guidelines for managing...

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