Last updated: 2 June 2023
See updates at the end of the post.
“Blue – Box” requirements
“Blue – Box” requirements concern additional information on labelling/package leaflet that may be required nationally in accordance with Articles 57 and 62 of Directive 2001/83/EC as amended. These requirements apply to products authorised via a National, Mutual Recognition or Decentralised Procedure only.
The “Blue – Box” requirements document has been updated. Changes in the document concern Italy. Here, you can view the track changed (June 2022) and clean (May 2023) documents
Guidance for industry to prevent and mitigate medicine shortages
The EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.
The guidance:
- describes the various stakeholders involved in the medicine supply chain and their responsibilities and role in the prevention and management of medicine shortages.
- provides ten recommendations for marketing authorisation holders, wholesalers, distributors and manufacturers to minimise the occurrence of medicine shortages and their impact. The recommendations include e.g.:
- informing national competent authorities of potential or actual shortages as early as possible and providing detailed information to better predict the possible impact and implement preventive measures;
- establishing robust shortage prevention and shortage management plans;
- optimising pharmaceutical quality systems and increasing resilience of complex, multinational supply chains
Source: EMA
Implementing the EU Health Technology Assessment Regulation
The Commission has published a factsheet with the above title.
The information is provided under the following headings
- What is HTA?
- What is in the EU HTA regulation?
- What will be assessed at EU and at national level?
- Timeline
- Governance structure
The Regulation (EU) 2021/2282 will become applicable on 12 Jan 2025.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 12 May 2023
You can view the PRAC meeting highlights here.
Report and minutes from the CMDh meeting held on 24-25 April 2023
The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each meeting and are usually published in the week following the CMDh meeting. The reports therefore only contain a subsection of the complete CMDh agenda and are used for a more timely communication of the most important outcomes. The CMDh minutes are a full record of the CMDh meetings (minus redaction of confidential content). They are adopted at the following CMDh meeting and subsequently published.
The report and minutes from the above meeting include (but are not restricted to) the following items:
1. Call for review for chemically synthesised and biological medicinal products regarding nitrosamine impurities
- Practical guidance for MAHs in relation to the Art. 5(3) Referral on Nitrosamines
- The CMDh agreed an update of its practical guidance for MAHs of nationally authorised products (incl.MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines.
- It has been clarified that if after finalisation of a MAA or the call for review a new potential risk for nitrosamines is identified and the MAH detects a nitrosamine during testing activities in the finished product, instead of immediately proceeding to step 3 (submission of variation(s)), the MAH should first submit a step 2 response.
- Here, you can view the track changed (Jan 2023) and clean (April 2023) versions of the practical guidance for MAHs
- Update of the assessment report template for the nitrosamine risk assessment for the outcome of step 2 – “nitrosamine detected”
- The CMDh also agreed an update of the assessment report template for the nitrosamine risk assessment for the outcome of step 2 – “nitrosamine detected”. You can download the updated template here.
- Guidance for the lead MS has been included in the template to give advice on the applicability of Q&A 22 for all scenario A cases, i.e. if there is a possibility for a higher interim limit and if there is a need for NMEG consultation.=
The updated documents have been published on the CMDh website under “Nitrosamines”.
2. Templates for CMS comments during DCP
- The CMDh agreed an update of the templates for CMS comments during DCP (D100, D145, D205).
- It was noted that in a footnote of the templates, it is stated that for Art. 10(3) applications with a centrally authorised product as reference product, the product name in RMS and all CMS must be the same.
- As this requirement is only applicable to Art. 10(1) applications, reference to Art. 10(3) has been deleted from the footnote.
- The updated templates have been published on the CMDh website under “Templates > Assessment Reports > DCP”.
You can download the templates at the links provided below:
D100 CMS Comments (Apr 2023)
D145 CMS comments (Apr 2023)
D205 CMS Comments (April 2023)
3. Template for the End of Procedure in MRP/RUP
The CMDh agreed an update of the template for the End of Procedure in MRP/RUP to reflect the new process with regard to renewals. The updated template has been published on the CMDh website under “Templates > Assessment Report. You can download it here.
4. Product name for MRP/DCP hybrid application with centrally authorised product as reference medicinal products
The CMDh:
- discussed if the requirement for MRP/DCP for generic medicinal products (authorised under Art. 10(1)), that have a centrally authorised product as RefMP, to have the same product name in all MSs, is also applicable to hybrid medicinal products authorised under Art. 10(3). Reference was made to the DCP CMS comments templates that mentions this is applicable to both legal bases in that context.
- was made aware of discussions on this issue in the NtA meetings that took place in 2016 and 2017, which resulted in an update of NtA Vol. 2A, Chapter 1. The NtA only makes reference to generics products authorised under Art. 10(1) for the requirement to have the same name in all MSs where they are authorised.
- agreed that the DCP CMS comments templates should be updated to delete reference to Art. 10(3)
- The updated documents will be published on the CMDh website
Updates
| Date | Update |
|---|---|
| 2 June 2023 | 1) The deading Report from the CMDh meeting held on 24-25 April 2023 was updated to Report and minutes from the CMDh meeting held on 24-25 April 2023 and link added to the minutes from the meeting. 2) The following were added under the heading Report and minutes from the CMDh meeting held on 24-25 April 2023 |
| 26 May 2023 | Heading “Blue – Box” requirements and relevant content added. |
| 17 May 2023 | Added heading Guidance for industry to prevent and mitigate medicine shortages and relevant content. |
| 16 May 2023 | Added heading Implementing the EU Health Technology Assessment Regulation and relevant content. |
| 13 May 2023 | Added link to PRAC meeting highlights. |