CMDh News – January 2016
05.02.2016
CMDh positions following PSUSA procedure for only nationally authorised products
The CMDh, having considered the PSURs on the basis of the PRAC recommendations and the PRAC assessment reports, agreed by consensus on the variations of the marketing authorisations of medicinal products containing the following active substances:
- Apomorphine
- Bismuth subcitrate potassium/metronidazole/tetracycline
- Gadobenic acid
- Gadobutrol
- Gadodiamide
- Gadopentetic acid
- Gadoteric acid (IV and intravascular formulations)
- Gadoteridol
- Gadoxetic acid disodium
- Iodine (131I) iobenguane
- Milnacipran
- Oxaliplatin
- Pamidronate
- Ticlopidine
Further information regarding the above-mentioned PSUSA procedures, including information on the implementation, will be published on the EMA website.
Outcomes of informal PSUR work-sharing procedures
The CMDh has adopted the conclusions of PSUR assessments for:
- Alprazolam
- Fluconazole (update)
- Mefloquine
- Praziquantel
- Valaciclovir
which may require changes to the product information or introduction of other risk minimisation measures.
The public summaries will be published on the CMDh website under "Pharmacovigilance, PSURs, Outcome of informal PSUR worksharing procedures”.
MAHs of the products concerned should implement the outcome of the assessment by the appropriate variation or other procedure (as advised) within 90 days of publication.
PSUSA procedure on trandolapril/verapamil adopted in November 2015 - Follow-up
Following the outcome of the PSUSA procedure on trandolapril/verapamil in November 2015, the CMDh has agreed on a corresponding wording for the warning on the interaction between dabigatran and verapamil to be implemented in medicinal products containing verapamil as monocomponent or verapamil in other combinations.
The wording that should be included in the product information of concerned products is available on the CMDh/HMA webpages.
PSUSA procedures on amlodipine besilate/ramipril adopted in December 2015 - Follow-up
Following the outcome of the PSUSA procedure on amlodipine besilate/ramipril in December 2015, the CMDh has agreed on a corresponding wording for the safety changes to be included in products containing the monocomponents.
The wording that should be included in the product information of concerned products is available on the CMDh/HMA webpages.
Regulatory Information on the Article 57 database
On 17 December 2015 the EMA Management Board considered that the Article 57 database is functional for the purpose of notifications of changes in QPPV and the location of the PSMF information. From 1 February 2016 Marketing Authorisation Holders no longer need to notify EMA (for centrally authorised products) and National Competent Authorities (for nationally authorised products) of changes to the QPPV or PSMF location by submitting a type IAIN variation.
Guidance documents by the CMDh for MRP/DCP products are under preparation.
More information for Marketing Authorisation Holders about the Article 57 database is available on the HALMED portal (in Croatian).
Implementation of the Falsified Medicines Directive
In preparation of the implementation of the safety features according to the Falsified Medicines Directive, the CMDh has agreed to update the annotated QRD template for MRP/DCP to include information on the unique identifier. The changes are in line with the changes for the QRD template in the centralised procedure.
The QRD template along with further information on the implementation of the safety features will be published as soon as the delegated act on the safety features is published.
Regulation (EC) No 1234/2008 on variations
The CMDh has agreed an update of the Questions and Answers on variations. Question 3.3 was revised to specify the timelines for implementation of outcomes of PSUSA procedures concerning CAPs and NAPs, especially for products not included in the procedure itself. A new Q&A was added to the document on details regarding the submission of safety relevant variations for several purely national marketing authorisations.
The updated document will be published on the CMDh website under "Questions and Answers”.
The CMDh further agreed an update of the examples for acceptable and not acceptable groupings for MRP/DCP products. New acceptable groupings have been added and a new heading has been introduced for submissions acceptable as single change instead of grouping.
The updated document will be published on the CMDh website under "Procedural guidance, Variation”.
Update of Questions and Answers on Pharmacovigilance legislation
The CMDh has agreed an update of Question 2 of the Q&A document on Pharmacovigilance legislation in order to clarify the submission of new/updated RMPs. Question 7 has also been updated to align it with the updated information given in Q&A 3.3 on variations (see above).
The updated document will be published on the CMDh website under "Questions and Answers”.
Revision of Core SmPC and Package Leaflet for Hormonal Replacement Therapy products
The CMDh has agreed a new version of the core SmPC and package leaflet for hormonal replacement therapy products following a PRAC signal recommendation regarding risk of ovarian cancer.
Further information on the PRAC recommendation on the safety signal related to HRT products adopted at the PRAC meeting of 30 November - 3 December 2015 can be found on the EMA website.
The updated Core SmPC and Package Leaflet have been published under "Product information, Core SmPC/PL”.
News from the CMDh January meeting are available on the CMDh/HMA webpages.
