EXPERT ADVICE

otc-product

Manufacturing OTC products for the US: the cGMP

The quality of a drug product is of the utmost importance to the consumer and to the brand whose reputation relies on manufacturing safe and effective drug products. The US Food and Drug Administra...

12 September 2019 | EXPERT ADVICE
dispositifs médicaux

Medical devices: new European regulation to be applied in 2020

In May 2020, the medical device regulation will start applying in the European Union (Regulation (EU) 2017/745). This regulation came into force in 2017 and repeals the previously existing directiv...

29 August 2019 | EXPERT ADVICE
Obligations d'étiquetage cosmétique aux États-Unis

Cosmetic labelling requirements in the United States

One of the key factors in bringing a new cosmetic product to the market is ensuring that your labelling is compliant. In the United States, cosmetic labelling is regulated by the FDA under the Fede...

18 June 2019 | EXPERT ADVICE
Comprendre les réglementations cosmétiques au Canada

Understanding Canada's cosmetic regulations

Health Canada regulates cosmetics under the Cosmetic Regulations of the Federal Drug Act. Cosmetic products in Canada do not require approval prior to marketing, however they must be notified once ...

26 April 2019 | EXPERT ADVICE
Enregistrer des cosmétiques aux USA : Voluntary Cosmetic Registration Program (VCRP)

Cosmetic registration in the United States - the Voluntary Cosmetic Registration Program (VCRP)

The US Food and Drug Administration (FDA) regulates cosmetic products under the Federal Food, Drug, and Cosmetic Act. While the law does not require that cosmetic products or ingredients (with the ...

05 March 2019 | EXPERT ADVICE
Enregistrer des produits OTC aux États-Unis

Over-the-Counter drug registration in the United States

An Over-the-Counter (OTC) drug is a product that is generally safe and effective for use without seeking help from a health professional. There can be a fine line between when a product is consider...

19 February 2019 | EXPERT ADVICE
Mon produit est-il un cosmétique, un OTC ou les deux ?

Is my product an Over-the-Counter drug, a cosmetic, or both?

There can be a fine line between when a product is considered a Cosmetic, an Over-the-Counter drug, or both. It is important to make a clear distinction, as regulations differ between each category...

18 February 2019 | EXPERT ADVICE
L'Autorisation de Mise sur le Marché d'un produit biocide identique

Same biocidal product Marketing Authorisation

According to the European regulation N°528/2012, industrials who wish to submit a request for the Marketing Authorisation (MA) of a product have to submit a dossier in the country in which they wa...

02 July 2018 | EXPERT ADVICE
Produits biocides : l'Autorisation de Mise sur le Marché simplifiée

Biocidal products: simplified marketing authorisation

Biocidal products are strictly regulated at European and national scales. Therefore, the regulation's goal is to make sure that each and every biocidal product put on the market be truly efficient ...

14 June 2018 | EXPERT ADVICE
Biocides : L'Autorisation de Mise sur le Marché nationale et la reconnaissance mutuelle

Biocidal products: national Marketing Authorisation and mutual recognition

Biocidal active substances and biocidal products are addressed in a European regulation (No 528/2012) that aims at harmonising the marketing authorisati...

15 May 2018 | EXPERT ADVICE