263 documents
Assessment report Chia seed, applicant Bravo Foods B.V.
A report on the assessment of chia seed by the company Bravo Foods B.V. for substantial equivalence to chia seed, which has...
MEB 47: Assessment criteria for combination packages
The Medicines Evaluation Board (MEB) has described the terms and conditions which are to be used to assess applications for...
Assessment report DHA-rich algal oil, applicant Changsha Sunnycare Inc.
A report on the assessment of DHA-rich algal oil by the company Changsha Sunnycare Inc for substantial equivalence to DHA-rich...
MEB Annual Report 2016: Appendices
Assessment report chondroitine sulphate, applicant Gnosis S.p.A.
A report on the initial assessment of chondroitine sulphate by the company Gnosis S.p.A.
Empty SPC template – QRD 8.1 (MRP/DCP/national)
Influenza strains: Dutch translation of active substances 2017/2018
The Medicines Evaluation Board (MEB) has confirmed the Dutch translation for the active substances for influenza strains for...
Assessment report Chia seed, applicant Tradin Organic Agriculture B.V.
A report on the assessment of chia seed by the company Tradin Organic Agriculture B.V. for substantial equivalence to chia...
Overview of approved compassionate use programmes
The MEB can give permission for bringing a medicinal product on the market that has not (yet) been granted a marketing...
MEB 48: National informed consent application
An Article 10c 'Informed Consent' application (article 10c of Directive 2001/83/EC) is an application for marketing...