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So far sv-user has created 43 blog entries.

European decision: classification of a FSMP from Denmark

At the request of Denmark, the Committee held an exchange of views on the classification of a product as food for special medical purposes (FSMP). The product in question is a tablet for the dietary management of lack of alphalipoic acid in diabetic neuropathy. Member States noted that similar products are placed on the market […]

November 14th, 2016|

Speaker at an international workshop at Brussels 30th of september

There is a workshop at Brussels (HCE program 09-2016) about health claims, food supplements and demarcation between food and drug: 5th Supplement Claims workshop by Health Claims Europe, focusing on the role EU nutrition and health claims could play for botanical extracts, supplements and herbal medicines.
If you want to participate, please feel free […]

July 6th, 2016|

EU 2016/128 for FSMPs published

2 th February 2016, Commission Delegated Regulation (EU) 2016/128 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes was published, will be enforced > 22th of february 2019.

Important points are

  • national notification, still open which documents have to […]
February 5th, 2016|

Technical guidance: Dossiers for FSMPs

EFSA has launched (17th of july 2015) an open consultation on its draft scientific and technical guidance for the assessment of products notified as food for special medical purposes in the context of Article 3 of Regulation (EU) No 609/2013. The guidance is for assisting in the preparation and presentation of well-structured dossiers for food […]

July 21st, 2015|