Tell me your name and I'll tell you… if you comply with the French Health Authority's recommendations!

On 22 February 2018, the French Health Authority (ANSM) published on its website its "Recommendations to applicants and holders of marketing and registration authorisations" on the names of medicines.

Choosing a medicine's name may be a factor of economic success, but it is above all a guarantee that it will be properly used when prescribed, given or administered.

The law requires that the invented name is chosen so as to avoid any confusion with other medicines and not to mislead as to the quality or properties of the speciality.

ANSM - which examines marketing authorisation (MA) application, registration and modification files and, if relevant, authorises the medicines' names suggested by the holder or applicant - published on its website its "Recommendations to applicants and holders of marketing and registration authorisations" on the names of medicines.

These recommendations are intended to MA or registration holders and applicants in the scope of a national procedure, a European mutual recognition or decentralised procedure (in the scope of a centralised procedure, holders and applicants must comply with the recommendations of the European Medicines Agency (EMA)).

The Agency invites holders and applicants, when submitting their files, to comply with its recommendations which aim to guide them, ensure homogeneity and transparency of its decisions, but also ensure legibility of its policy.

The basics of ANSM's recommendations

For invented names:

  1. Avoid confusion with other medicines and health products (for instance, medical devices, cosmetic products, food and food supplements). ANSM will notably pay attention to a potential orthographic and phonetic similarity. It is also important that the chosen name does not sow confusion as to the product's legal classification.
  2. Not to mislead as to the qualities, properties or composition of the medicine, in particular by avoiding names too close to terms designating diseases.
  3. Not to convey a promotional message in light of the medicine's therapeutic and/or pharmaceutical properties or composition, by avoiding the use of superlatives, Anglicism with a promotional connotation, the segment "DUO" or even common nouns or existing proper nouns.
  4. Choose a single-word name which includes no isolated numbers, abbreviations, isolated letters, etc. likely to sow confusion.
  5. Not to use standard terms defined in the scope of European pharmacopoeia (for instance, relating to the pharmaceutical form, packaging or other suggestive mention) to make up the invented name. These terms must mandatorily be placed after the name.
  6. Not to use a same name for a prescription medicine and an over-the-counter medicine.
  7. Avoid confusion between the name and International Non-proprietary Names (INN).

For common names:

  1. Use the entire common name, without omission or addition.
  2. Provide evidence of registration of the brand with the competent body.
  3. Possibility of including the name of the MA holder or the exploiting company in the name.
  4. For homeopathic medicines eligible for registration, use the common name of strains included in the composition.
  5. For herbal medicines, use the local name of the plant.
  6. For generic medicines, use the common name together with a brand or the name of the MA holder or exploiting company.

ANSM also gives recommendations as to the use of an umbrella trade mark regarding medicines only, which is defined as "the use of a same invented name for several over-the-counter medicines only which MAs are held by the same holder, having a different composition in active substances and different therapeutic indications". ANSM does not accept the use of an umbrella trade mark as ANSM now considers that it may cause risks to public health and sow confusion between medicines.

ANSM also refuses umbrella trade marks for medicines and products having different statuses due to the risks of confusions and errors of use.

Lastly, ANSM specifies the additional mentions of the name that are acceptable in some specific situations.

ANSM's recommendations must be taken into account carefully when choosing the medicine's name, in particular to encourage positive assessment and decision from the Agency and avoid incurring a risk of reclassification as medicines by virtue of their presentation, indirect advertising or even of a possible action brought by a competitor for unfair competition.

We remain at your disposal to give you our good practices and assist you in the choice of your products' names!

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