Posted 04 June 2012
By Alexander Gaffney
France's recently-formed National Security Agency of Medicines and Health Products (ANSM) has announced the launch of new advertising guidelines, which it says will transition the agency from a passive verification system to a system in which advertising must be approved before publication.
In its 31 May explanation of the "new methods of control" for advertising, ANSM notes requests for prior authorization must be sent to the agency per Article L.5122-9 of the Code of Public Health if the product has been on the market without significant problems. For product subject to reassessments of its benefit:risk profile, the product will not be allowed to be marketed until the reassessment is complete. Companies found to have submitted a suitable advertisement will be issued a "visa PM" to market their product.
Drugs available to consumers without a prescription, such as over-the-counter products, will also be subject to a priori advertising restrictions. ANSM said it will issue advertising visas known as "visa GPs" for certain products not found to have restrictions. Other products such as vaccines and smoking cessation products may also use promotional campaigns since they support "a public health goal," explained ANSM.
Visas for advertising prescription products will only be available during short windows of time in France: a two week period at the start of June (1-15) and a two month period at the end of the year (1 September - 31 October). ANSM notes "no application may be sent outside these periods" unless a drug has undergone a reassessment following pharmacovigilance reports. The schedule only affects 2012, and it seems likely the agency will adapt a schedule in the future with more dates to cover the March-April timeframe.
Advertisements for non-prescription products will to subject to a less restrictive control regimen, with applications for advertising visas available for a one-week period every month.
ANSM said it will respond to applicants for advertising visas within two months of the end of the filing period, meaning those applying for a visa on 1 September may not hear back until 31 December.
ANSM - New methods of control