News and Educations

CMDh News – June 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:

  • acitretin
  • ivermectin (topical use)
  • metroclopramide
  • perindropil.

MAHs of medicinal products containing perindropil in combinations should consider if the above mentioned outcome of the PSUSA procedures for perindropil is applicable to their products and should be implemented accordingly .

Further information regarding the above mentioned PSUSA procedures, including information on the implementation, will be published on the EMA website.

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 would like highlight that the agreed wording for the safety changes to be included in the product information of products containing amlodipine besilate or ramipril as monocomponents also applies to combinations of amlodipine besilate with other active substances as well as to combinations of ramipril with other active substances.

The wording that should be included in the product information of concerned products is available in the January 2016 CMDh press release, which can be found on the CMDh website.

Regulation (EC) No 1234/2008 on variations

The CMDh has agreed an update of the Questions and Answers on variations. Question 3.25 was added to clarify how MAHs should handle changes to dossiers linked to Ph. Eur. monograph updates resulting from the implementation of the new policy concerning the expression of the degree of hydration.

The updated document will be published on the CMDh website under "Questions and Answers”.

CHMP outcome on referrals pursuant to Article 13 of Regulation (EC) No 1234/2008 - Levonelle

Important new information is available as result of the Article 13 of Regulation (EC) No 1234/2008 referral procedure for Levonelle 1500mcg and associated names. All MAHs with marketing authorisations in place for levonorgestrel containing emergency hormonal contraceptives should review the currently available summary of key issues and CHMP conclusions (Q&A document) as well as the recommended changes to the product information published on the EMA website.

MAHs should take appropriate actions with regard to the important new information on the use of these medicinal products. The scientific conclusion of the CHMP will be available on the EMA website after the Comission Decision.

News from the CMDh June meeting are available on the CMDh/HMA webpages.