Documents

Heads of Medicines Agencies: Highlights of the 83rd Meeting

The 83rd Heads of Medicines Agencies (HMA) meetings (human, veterinary and joint) took place in Amsterdam from 16 February 2016 ...

Publication | 18-02-2016

ICMRA Zika virus disease press release

Medicines agencies worldwide - united in the “International Coalition of Medicines Regulatory Authorities (ICMRA)” - have joined ...

Publication | 09-02-2016

Assessment report Chia seed, applicant GCP Import & Export S.R.L.

Report on the assessment of chia seed by GCP Import & Export S.R.L. for substantial equivalence to chia seed, which has already ...

Report | 12-01-2016

Assessment report Chia seed, applicant Mardan B.V.

Report on the assessment of chia seed by the company Mardan B.V. for substantial equivalence to chia seed, which has already been ...

Report | 11-01-2016

Palfium (dextromoramide) 5 mg tablets - public assessment report suspension of marketing authorisation

Publication | 14-09-2015

Declaration accompanying a duplex marketing authorisation regarding the technical aspects of the readability of the patient information leaflet for pharmaceutical products for human use

Directive | 01-09-2015

Assessment report Anatabine, applicant Rock Creek Pharmaceuticals LLC

A report on the initial assessment of anatabine by the company Rock Creek Pharmaceuticals.

Report | 25-06-2015

Form to request withdrawal of a parallel import marketing authorisation

Form | 12-06-2015

Manual parallel import dossier structure

Policy document | 01-06-2015

MEB 18: Written and verbal opinion procedure for a proposed primary judgement by the MEB

The policy document Written and verbal opinion procedure for a proposed primary judgement by the MEB explains how the MEB ...

Policy document | 30-04-2015