News & events UK

Brexit

On 29 March 2019, the United Kingdom will leave the European Union. Unless the current negotiations set another date or provide for a transitional period, the EU-regulations will no longer apply to the United Kingdom, which will be considered a third country to the European Union as from 30 March 2019. The (very likely) scenario of a hard Brexit would have repercussions on "more than 3,000 medicines" exported or imported from France to the United Kingdom. The professional organisation of pharmaceutical companies operating in France (LEEM) points out that the United Kingdom is France's 4th largest export and 7th largest import trading partner and that a hard Brexit would pose customs and regulatory problems for trade in medicines. read more...

ANSM – MA – Translations

A new process has been established by the ANSM regarding the translations submitted at the end of mutual recognition or decentralised procedures (national phase). The declaration of conformity of the translations is now applicable to initial MA applications and renewals.

CPhI Worldwide: The World’s Leading Pharmaceutical Fair

CPhI Worldwide, has taken place at IFEMA, Feria de Madrid from 9th till 11th October 2018. During three days it has hosted more than 43,000 visiting pharma professionals and more than 2.500 exhibitors from more than 150 countries that have gathered at the event to network. After having been hosted previously by Barcelona in 2016 and then Frankfurt in 2017, this is the fifth time Madrid has hosted this event. Participating for the 11th time at CPhI, Medipha Santé’s booth 1H20 was perfectly positioned within Polepharma’s alliance. Medipha Santé was represented by its CEO, Luc Lamirault, its responsible pharmacist (EU-QPPV), Kevin Bondiguel , its regulatory affairs manager Maxime Chauveau and its legal consultant, Claudia Grohmann. CPhI worldwide was founded in 1990 as an international chemical and pharmaceutical trade fair and is today one of the largest pharmaceutical trade shows worldwide. The CPhI is divided into different areas to deal with very specific sectors within the pharmaceutical industry :
  • CPhI Worldwide: for pharmaceutical ingredients
  • Finished Dosage Formulation (FDF): for every aspect of the finished dosage supply chain
  • ICSE: for outsourcing solution providers, contract manufacturing and services
  • P-MEC: for pharmaceutical machinery, technology and equipment
  • InnoPack: for pharmaceutical packaging and drug delivery systems
Every sector of the pharmaceutical market is represented under one roof which makes attending CPhI Worldwide the most cost effective way to establish new business relationships, strengthen existing relationships and stay updated on the latest industry trends in a constantly changing market. The fair covers the whole spectrum of pharmaceutical manufacturing and ingredients sourcing, offering products and services that encomprise the entire supply chain.

Previous news

 
  • October 2017 : The ANSM published a Notice to Applicant regarding QR codes that can be affixed to the primary or secondary packaging, or to the package leaflet of a medicinal product.
 
  • October 2017 : Medicinal products have now a pictogram used to improve the visibility of the information on risks during pregnancy.
 
  • October 2017 : Medipha Santé will be present at stand 4.1D50 at CPhI congress 2017, which will take place in Frankfurt from October 24th to 26th.
 
  • September 2017 : The ANSM publishes its annual report for 2016.
 
  • May 2017 : Pregnancy pictogram: The decree edited on May 5th, 2017 indicates that a pictogram must be appended on the outer packaging of drugs or products with a teratogenic or foetotoxic effect before October 17th, 2017.
 
  • April 2017 : Candidacy of Lille for hosting the European Medicine Agency (EMA) France has decided to propose Lille as a candidate city as part of relocation of the EMA within a Member State of European Union.
 
  • March 2017 : The Ministry of Social Affairs and Health has set up for the general public and healthcare professionals a common portal to report undesirable health events suspected of being linked to health products, products of everyday life and acts of care. This first version of the portal is about all regulatory vigils such as pharmacovigilance, toxicovigilance, vigilance for medical devices, cosmetics, etc.
 
  • March 2017 : An agreement on mutual recognition of the inspections conducted on the manufacturing sites of drug products has been reached between the European Union and the United-States, and will enter into force on November 1st, 2017.
 
  • February 2017 : A new template T10 for the redaction of the product informations has been published by the ANSM.
 
  • January 2017 : The EDQM organises a webinar on elemental impurities in order to comment the impact of the implementation of ICH guideline Q3D, which is applicable for new marketing authorisations since June 2016, on the texts of the European Pharmacopoeia and on the assessment of CEP applications.
 
  • October 2016 : The eCTD specifications of EU Module 1 changed to version 3.0.1, currently in force since July 1st, 2016. The eCTD validation criteria also changed to version 6.1, to be in line with the updated EU Module 1.
 
  • October 2016 : Medipha Santé will be present at stand 3N40 at CPhI congress 2016, which will take place in Barcelona from October 4th to 6th.
 
  • September 2016 : The minister of Social Affairs and Health launched a national information campaign on generic medicinal products in order to reinforce confidence and knowledge on these medicines.
 
  • September 2016 : The ANSM published a draft of recommendations regarding the names of medicinal products, which is subject to a public consultation until November 30, 2016.
 
  • July 2016 : Medipha Santé is now part of the GEMME, the association « Generic same medicine » which represents French professionals and manufacturers of generic and biosimilar medicinal products.
 
  • June 2016: National recommendations have been established by the ANSM for the submission of good quality translations in case of application for the modification of marketing authorization issued from Mutual Recognition Procedure (MRP) or decentralized procedure (DCP).
 
  • May 2016 : ANSM has adjusted its organization through internal process optimisation measures. The « Products » departments have been reorganized in order to rebalance their activities and improve the performances of the Agency. The article is available here.
 
  • May 2016: A new report related to the biosimilar medicines is available on the ANSM. It evokes the possibility of interchangeability during treatment between two biological medicines (reference medicine and/or biosimilar medicine) under certain circumstances.
 
  • April 2016: the ANSM has set up a public consultation for an update version of good pharmacovigilance practices and made available on agency website.
 
  • April 2016: the ANSM has published in September 2015, to the Exploitant Company, a guide specifying the reporting of improper medical prescription. The guide is available online.
 
  • October 2015 : Medipha Santé will be present at the CPhI Congress in the Feria de Madrid, stand 3B30, from October 13th to 15th 2015.
 
  • August 2015 : Evolution of Medipha Santé pharmaceutical status. Besides its status of Exploitant, Medipha Santé has obtained from ANSM, on August 14th 2015, an authorization to expand its pharmaceutical activities in the importation operations limited to batches certification and sample models storage.
 
  • August 2015 : The free sale certificates faciliting the exportation of the human use medicines, the medical devices and the in vitro diagnosis medical devices will be delivered by the Chamber of Commerce and Industry of Paris - Ile de France (CCI) from October 2015, in agreement with the Convention signed on 17th July 2015 by the CCI and the ANSM. The free sale certificates are currently delivered by the ANSM.
 
  • July 2015 : Starting from the 1st July 2015, the eCTD format became mandatory to submit a new marketing authorization application for the decentralized procedure (DCP).
 
  • July 2015: The ANSM warns users against softwares and mobile applications in the health field in light of important current rise and their varied uses. Indeed, certain of these softwares have a medical aim, and consequently, the ANSM wishes that they have to be required by medical devices legislations and hold CE marking, entailing a monitoring. The resort to health professionals advices in hence recommended for more safety.
 
  • July 2015: New application forms are available on the Eudralex, concerning MA applications, variations and renewals. Changes relate only to centralised procedures, from the 1st of July electronic application forms (eAF) must be used for this kind of procedure.
 
  • July 2015: A new notice to applicants for MA of medicinal products for human use relating to the electronic submission to the ANSM via the CESP is available on the website of the ANSM. This notice to applicants details characteristics of the CESP, and the submission terms and conditions of dossiers in the framework of the pilot phase.
 
  • May 2015 : The EMA has announced the launch of the EMA´s medical literature monitoring service (MLM). The EMA will be responsible for monitoring a number of substances and selected medical literature to identify suspected adverse reactions with medicines authorised in the European Union, and for entering the relevant information into the EudraVigilance database. The service will cover 50 active chemical substance groups in July 2015 and should reach full operational levels in September 2015. This new service represents an important simplification for the pharmaceutical industry.
 
  • May 2015 : The team of Medipha Santé ran 3,1 miles during the Foulées de Courtabœuf!
 
  • April 2015 : The ANSM has opened the portals dedicated to the registration of the annual update of the site master files for the pharmaceutical sites and of the "Responsible Pharmacist" on its website.
 
  • February 2015 : Publication of Recommendations for implementation of the ICH guideline Q3D on elemental impurities, one of the most complex changes in regulations pertaining to impurities seen by the pharmaceutical industry.
 
  • Medipha Santé celebrated one’s tenth birthday in 2014!
 
  • Medipha Santé was present at the CPhI Congress in Paris-Villepinte from October 7th to 9th 2014.
 
  • We are now a DIA member!
 
  • ANSM has published a new Notice to applicants relating to the export notifications and certificates for human medicinal products. The new terms given in this document are coming into force from September 1st 2014.