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Communication agency - Eliott & Markus

Month: April 2020

COVID-19: The French competent health authority (ANSM) modifies the advertising visas calendar

Posted on by Marie SANCHEZ

Due to the state of health emergency established by the emergency law of March 23rd, 2020, the ANSM published earlier this month a new schedule for filing and granting advertising visas for medicinal products intended for the general public (GP) or healthcare professionals (HCP).

This new calendar results from the application of Ordonnance n°2020-306 of March 25th, 2020 relating to the extension of deadlines expired during the health emergency period and to the adaptation of procedures during that same period, which sets out a legally protected period until June 24th, 2020. The purpose of this legally protected period is to allow the adjustment of the deadlines and procedures for the examination of files by the administrative authorities.

In practice, the consequences of this modified timetable are as follows:

  • For advertising visas that expire during the legally protected period: they will be automatically extended until December 31st, 2020, provided that no decision aiming at modifying or terminating them has been issued before March 12th, 2020;
  • For advertising visas which should have started during the legally protected period, the filing periods will be merged with the filing periods normally foreseen at the end of the legally protected period. The filing periods for these visas will therefore be:
    • Advertising visas for GP: from June 25th to July 3rd, 2020;
    • Advertising visas for HCPs: from June 25th to July 24th, 2020.
  • For advertising visas which started before the legally protected period, the evaluation periods are suspended and will resume for the period remaining to run on June 24th, 2020. Consequently, the evaluation period of these visas will end on the following dates:
    • Advertising visas for GP: August 12th, 2020;
    • Advertising visas for HCPs: July 15th, 2020.

The ANSM specifies that beyond these dates and in the absence of an express response from the ANSM, visas will be deemed tacitly granted. However, no implicit visa will be acquired during the legally protected period.

  • Exceptionally, the ANSM authorizes the use of promotional materials normally intended to be distributed during medical visits and for which the advertising visa is still valid, to be used during visits carried out remotely through the internet or telephone platforms, provided that such use and communication is performed in compliance with the rules described in the Charter for the communication and promotion of health products on the internet.

These postponements will inevitably result in a bottleneck of the evaluation services at the end of the legally protected period. In order to avoid these complications, but also to limit the risk that many advertising visa requests be rejected, the ANSM recommends that manufacturers:

  • Prioritize their advertising visa requests;
  • Limit their requests to 3 advertising materials per product (all pharmaceutical forms and all dosages combined), per medical device or in vitro diagnosis medical device;
  • Limit their requests to 3 advertising materials per therapeutic indication in the case of products with several therapeutic indications.

The entry into application of Regulation (EU) 2017/745 of April 5th, 2017 relating to medical devices (MDR) is postponed by one year

Posted on by Marie SANCHEZ

The EU authorities have decided to postpone the entry into application of the MDR, initially scheduled on May 26th, 2020, to May 26th, 2021. The authorities explain this decision by the critical need to avoid any shortages in stock of vital medical devices (MD) during the COVID-19 pandemic. It is also a way to ensure that the parties concerned will be able to implement and make a correct application of the MDR, which would have been impossible on May 26th, 2020, due to the extraordinary difficulties generated by the sanitary crisis and the complexity of MDR itself. 

Regulation (EU) 2020/561 of April 23rd, 2020, published in the OJEU of April 24th, 2020, therefore provides the following modifications to the MDR:

– The application of certain provisions of the MDR is postponed as follows:

  • The adoption of the common specifications is postponed to May 26th, 2021;
  • Single-use MDs which were placed on the market before May 26th, 2021 in accordance with Directive 93/42/EEC can be reprocessed;
  • Reusable MD that must bear the UDI carrier on the MD itself can remain on the market, provided that UDI carrier is placed on the label and on all higher levels of packaging, according to the following schedule:
  • implantable MD and class III MD: from May 26th, 2023 onwards;
  • class IIa and IIb MD: from May 26th, 2025 onwards;
  • Class I MD: from May 26th, 2027 onwards.
  • The deadline for the operational functioning of EUDAMED is extended to March 25th, 2021;
  • Member States shall notify to the Commission the rules on penalties for infringement of the provisions of the MDR no later than February 25th, 2021.

– Adaptation of the transitional provisions:

  • As from May 26th, 2021, any publication of a notification relating to a notified body in accordance with the directives is invalidated;
  • Class I MDs for which the declaration of conformity was drawn up before May 26th, 2021 and for which the conformity assessment procedure under the MDR requires the intervention of a notified body, or who have a certificate issued under the directives which is still valid, may be placed on the market or put into service until May 26th, 2024, provided that from May 26th, 2021 onwards, they continue to comply with the directives and there is no significant change in design and destination of the MD;
  • MDs legally placed on the market in accordance with the directives before May 26th, 2021 may continue to be made available on the market or put into service until May 26th, 2025;
  • MDR-compliant MDs can be placed on the market before May 26th, 2021;
  • Conformity assessment bodies conforming to the MDR can be designated and notified before May 26th, 2021 and thus implement the conformity assessment procedures established by the MDR and issue certificates in accordance with the MDR before May 26th, 2021;
  • MDs manufactured using tissues or cells of animal origin, or their derivatives, which are non-viable or made non-viable and which have been legally placed on the market or put into service in accordance with the rules in force in the Member States before May 26th, 2021 may continue to be placed on the market and put into service in the Member States concerned;
  • Clinical investigations carried out in accordance with the directives and which started before May 26th, 2021 may continue to be conducted. However, as of May 26th, 2021, notification of serious adverse events and device failures will be made in accordance with the MDR.

– Setting up of a derogation:

  • During the period from April 24th, 2020 to May 25th, 2021, any competent authority, upon duly justified request, may authorize the placing on the market or the entry into service, in the territory of the Member State concerned, of a specific MD that has not been evaluated in accordance with the applicable procedures, but the use of which is in the interest of public health or the safety or health of patients;
  • The derogatory authorizations granted on the basis of Directives 90/385/EEC and 93/42/EEC before April 24th, 2020 are maintained;
  • The European Commission may decide to extend the derogatory authorization obtained to the territory of the EU, for a limited period of time and on conditions it defines, in case of exceptional reasons related to public health or to safety or health patients.