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N-nitrosamine contamination in drugs: European Pharmacopoieia review and practical applications

N-nitrosamines are organic compounds that are possibly carcinogenic to humans. They are contained in some foods, in drink water supplies, and some classes...

Switzerland – EU: MRA and Swiss authorised representative

The agreement 0.946.526.81 on the mutual recognition of conformity assessment (MRA) has made easier, in the last 22 years, the free exchange...

Food additives, flavours and enzymes: new operative procedures for EFSA authorisations

Food additives, flavours and enzymes are three categories of substances entering and playing a crucial role in the manufacturing chain of foods. The...

I Botanicals

Botanicals and dossier, the use of plants in food supplements is still regulated nationally

At the European level, the concept of “botanicals” is well known and has given rise to interesting cooperation projects between...

The importance of standards for translations

In a globalised world, harmonisation and standards are key elements allowing the acceptance and circulation of goods, systems, methods and applications. A standard is...

The marketing of veterinary drugs

The marketing of veterinary medicinal products is subject to the release of the relevant authorisation by the competent authority. In...

The qualifications of specialised translators

The translation of specialised texts generally requires a deep linguistic competence (both in the source and target language), a good...

The complex world of biocides: all supporting guidelines

We often talk about biocides and biocidal properties of a product, but the meaning of these terms is not always clear to everyone....

The registration of medical devices in the databases

As of 26 May 2021, Regulation (EU) 2017/745, replacing and repealing Directive 93/42/EEC will apply to medical devices. The requirements provided...

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