Pharmaceutical Marketing Authorisation Application for France

Redacting a pharmaceutical marketing authorization application according to requirements imposed by ANSM – the National Agency for the Safety of Medicines and Health Products in France is a laborious process. The numerous rules surrounding the content and format require applicant vigilance and enhanced attention to detail.

We subtitled a video and translated a pdf guide, provided originally in French by the ANSM, to help you acquire a better understanding of current requirements.

Watch the video below to see how to redact a marketing authorization application in accordance with the template expected by ANSM. The video focuses on application formatting. English and French subtitles are available. The original video is available without subtitles, and in French only, on the ANSM website.

Change the language according to your preference by clicking the cogwheel in this video.

We provide here as well a translation into English of the ANSM recommendations for drafting Marketing Authorizations using the required format (original document is in French). You can pause and play the video to read the text. You can also download our translation into English and read the translation in pdf format.

RECOMMENDATIONS RELATING TO THE WRITING OF ANNEXES TO THE MARKETING AUTHORISATION IN FRANCE

o   Implementation Date: February 15, 2017.

Since January 1, 2002, style sheets, generated in MS Word, have been put in place to facilitate the production of annexes to Marketing Authorizations (AMM) and to allow the publication of the Summary of Product Characteristics (SPC) and the Patient Information Leaflet (PIL) on the Medicinal Products Directory and since 2013 on the Public Medicinal Products Database.

For this purpose, ANSM provides the following:

§  a “complete” template: to be used in the context of an initial MA application, a renewal, an ATU (Temporary Marketing Authorisation), a variation request or as part of a request for variation within a European procedure (translation proposal);

§  a “partial” template: this template is to be used only in the context of a request for variation of MA for a national procedure, to make a class correction (> 10 specialties) or for administrative variations (changes in address, holder, and operator). Only the sections concerned by the variation request will be completed.

o Warning: for any new request using this new style sheet format, the complete template consolidated with the 4 annexes must be used.

Some of the most important recommendations in the document are also reproduced below in English.

Reference Texts

The T10 version of the style sheet conforms to version 10 of the European QRD template. The content of the sections corresponds to the French translation of QRD template 10.

Recommendations for Drafting a Pharmaceutical Marketing Authorisation Application according to French Requirements

The drafting of the annexes to the MA from the downloaded template must obey a few important principles:

Use only the styles listed in the template with titles beginning in “Amm”.

Do not modify the wording of BLUE HEADINGS AND SUBHEADINGS.

The mention “xxx” present in certain headings of the patient information leaflet must be replaced by the appropriate name.

Example: in the leaflet, the name of the drug is: “NAME OF THE MEDICINAL PRODUCT IN THE PACKAGE LEAFLET 3 mg, tablet”

Page, Paragraph, Line Breaks

It is advisable to avoid the use of page, paragraph, line breaks and to prefer the function “Keep with next: Home/ Paragraph / Line and Page Breaks”: under Pagination check Keep with next and Keep lines together.

Advantage: if the layout must change for one reason or another, the paragraph layout is automatically preserved, whereas the use of line breaks requires reworking the layout.

Line breaks should also be avoided; prefer Home>> Paragraph>> increase the number of points of spacing before or after.

Writing conventions: adapted from the European template

<> (chevrons) Optional phrase the wording of which, if chosen, should not be changed.

[] (square brakets) Editorial advice. These sentences cannot be kept in the body of text.

{} (braces) The content must be replaced by what it designates.

[] Highlighted Text This format can be used to highlight text that will not appear in the document printed by the applicant.

Do not modify the wording of the section headings written in blue.

Do not remove headings written in blue.

Whenever a section is not filled in due to lack of data, or if the section information is outside the scope of the application, the mention “Not applicable” must always be provided.

In the context of requests for the variation of the Marketing Authorization giving rise to partial corrections, sections which were left unchanged must bear the mention ” Not modified “.

Do not create headings or subheadings.

The numbering and hierarchy of the sections proposed in the template must be respected.

SCIENTIFIC SYMBOLSFor the sake of compatibility with all browsers, it is recommended to use the scientific symbols available on an alphanumeric computer keyboard. To avoid all sources of error, product strengths expressed using special characters must be written in full. Example: microgram instead of µg.
SPACESUse of non-breaking spaces (CTRL + Shift + Space) to avoid the separation of a number and its unit of measurement for example. Use of non-breaking hyphens (CTRL + Shift + Hyphen). Use of Keep lines together / Keep with next, Page, paragraph, or line break: insertion of blank lines is not permitted.
REFERENCESIn the event of a reference or cross-reference in the SPC, only the number of the section and not its entire title should be provided.
PRODUCT NAMEThe long name “xxx” symbolizing (invented) NAME strength, pharmaceutical form applies in all sections 1. NAME OF THE MEDICINAL PRODUCT (SPC / Package Leaflet / Labeling), as well as in the headings and sub-headings of the package leaflet. Use the search / replace function to change the code “xxx” to the (invented) NAME, dosage, pharmaceutical form, all at once. The short name NAME (invented) applies in body text only.

How to Handle Special Cases When Drafting a Pharmaceutical Marketing Authorisation Application for France

Holder, Operator, Manufacturer

If the holder, operator and manufacturer functions are fulfilled by the same entity, the same information should be repeated in the 3 sub-headings and not deleted (or grouped together).

The company name must be written in CAPITAL LETTERS + AMMBodyTextBold

The address must be written in CAPITAL LETTERS + AMMBodyText

🚫Do not do this:

Holder, Operator and Manufacturer

HOLDERNAME
HOLDERADDRESS1
HOLDERADDRESS2 HOLDERPOSTCODECITY
HOLDERCOUNTRY

👍Do this instead:

Holder

HOLDERNAME
HOLDERADDRESS1
HOLDERADDRESS2 HOLDERPOSTCODECITY
HOLDERCOUNTRY

Operator

OPERATORNAME
OPERATORADDRESS1
OPERATORADDRESS2 OPERATORPOSTCODECITY
OPERATORCOUNTRY
[or<Not declared/ To be filled in later>]

Manufacturer

MANUFACTURERNAME
MANUFACTURERADDRESS1
MANUFACTURERADDRESS2 MANUFACTURERPOSTCODECITY
MANUFACTURERCOUNTRY

Several Active Ingredients Interactions Section

NB:   If the speciality contains several active ingredients and these are the source of individualized sub-headings, apply the AmmAnnexTitre3 style and change the selected title to All Caps.

How to Write the Post Address for a French Pharmaceutical Marketing Authorisation Application

The French Postal Service expects certain rules to be followed when writing the address, of which here are a few reminders:

  • the order of the information goes from the name of the addressee to the locality or country,
  • a maximum of 6 lines of text,
  • a maximum of 38 characters (including space) per line,
  • no punctuation, underscore, italics starting from line number and street name,
  • the last 3 lines of an address are in capital letters,
  • the entire address must be left-aligned.

How to Format Tables Included in the Pharmaceutical Marketing Authorisation Application

The drafting of tables is subject to specific recommendations. Tables must be centred on the page, written with the appropriate styles: AmmCorpsTexte (AmmBodyText) or AmmCorpsTexteGras (AmmBodyTextBold). If necessary, the font can be reduced to a smaller size (to keep the entire table on the same page).

IMPORTANT:
Only one item of information is permitted per table cell.
Do not add several items of distinct information in a single cell.
The borders of the table and cells can be hidden if necessary.

This article, while not exhaustive, provides a level of detail not previously available in English, on how to draft a marketing authorization application that follows current requirements in France. If you have any questions related to the content, or need assistance with formatting the style sheet correctly, please get in touch.