Guidance Documents on Variation Notifications Updated

On the website of the HMA (Heads of Medicines Agencies), under the heading "Variations", you will find the "Guidance Documents" relating to the updated "Variation Regulation" (Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorizations for medicinal products for human use).

Amongst a large number of other documents, these include the so-called "Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure". These consist of 8 chapters, which were last updated in October 2024. Chapters 3 and 6 were revised again in January 2025:

Chapter 3: CMDh BPG for the Processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure
Updates have been made to subsection 1. Introduction and Annex II.

Chapter 6: CMDh BPG for the Processing of (Super-)Grouped Applications in the Mutual Recognition Procedure
Chapter 6 contains changes in the subsections 2. Application, 4. Validation of the application and 6. Finalisation of Procedures as well as in the appendices Annex I and Annex II.

Comments

Post a Comment

Popular posts from this blog

FDA describes detailed CAPA Procedure in Warning Letter

An FDA Warning Letter is a formal communication from the US Food and Drug Administration (FDA) notifying a company or individual of regulatory violations. These typically describe observations made during an inspection and list violations found (referencing the specific sections of the FD&C Act, the Code of Federal Regulations (CFR), and other applicable laws as appropriate). In addition, specific measures are listed that the recipient must take to remedy the violations. It does not go into great detail, especially not with regard to instructions on the desired procedure. In a Warning Letter issued to Sun Pharmaceutical Industries Limited (India) at the beginning of July, this is now different. It describes in great detail what the FDA considers to be appropriate CAPA measures in a specific case. What happened? The company was criticised for not adequately cleaning and maintaining the equipment used to manufacture drug products. According to the company's response, a defective ...
Read more

Difference between review and verification

The difference between review and verification lies in their purposes and methodologies: - **Review** involves evaluating the suitability, adequacy, or effectiveness of an object to achieve established objectives. It is a process of determining whether the design or product meets the required standards. Reviews can occur throughout the design phase and at key milestones in the development process. Examples include management reviews, design and development reviews, and peer reviews[4]. - **Verification** ensures that specified requirements have been fulfilled by providing objective evidence. This can involve inspections, testing, reviewing documents, and performing alternative calculations. Verification occurs after the completion of development stages, prior to validation, to confirm that the product meets all specified design and requirement specifications[4]. In summary, review evaluates the design's ability to meet objectives, while verification confirms that the product meets ...
Read more

FDA Warning Letter Missing Ongoing Stability Studies for APIs

Company Antaria Pty. Ltd, Australia Synopsis  1.Inadequate Investigation  2. Own Analytal Methods used but proved to equivalent to USP methods 3.Annual Stability missed 1.Failure to adequately investigate and document out-of-specification results and implement appropriate corrective actions . Your firm manufactures API (b)(4) USP, labeled in part to be the active ingredient used in (b)(4). You failed to adequately investigate out-of-specification (OOS) test results. Specifically, your firm lacked adequate investigations and corrective actions for numerous OOS results obtained during laboratory testing of your API, including assay and loss on ignition (LOI) testing. The root causes were not clearly defined nor adequately documented, and lots with OOS results were released by your quality unit (QU). In your response, you state that staff turnover and insufficient staff training attributes to the lack of competency in good laboratory practices . Additionally, you state that you...
Read more