Medipha Santé: the expert in pharmaceutical operations and regulatory affairs
Medipha Santé: the expert in pharmaceutical operations and regulatory affairs Working since 2004 as an operating and certifying laboratory for the pharmaceutical industry, Medipha Santé has a portfolio of complementary services, which it undertakes to provide to European and international manufacturing partners.
Medipha Santé or the facilitator of access to medicinesFor almost 20 years, Medipha Santé has been supporting the pharmaceutical industry, its customers, but also French hospitals and their patients. Thanks to its status as an operator and importer, this French company has been able to develop a large network of partnerships with national and international pharmaceutical companies. This has resulted in a hundred or so clients worldwide and nearly 350 dossiers submitted each year to the French Agency for the Safety of Medicines and Health Products (ANSM), as well as a multitude of other European procedures. This status allows Medipha Santé to build a wide range of services in the health field, but also to be of significant assistance to its clients. Its competences include pharmacovigilance, regulatory affairs, quality assurance and the marketing of drugs in the city and in hospitals. With this growing experience and legitimacy, Medipha Santé facilitates the market access of innovative medicines for public health. The marketing of essential anesthetics for the treatment of intensive care patients is a good example of the company's role as a facilitator of access to care for patients and support for professionals. This support is all the more crucial in these times of health crisis and shortage of essential medicines. Enriched expertise for complete support The services designed and deployed by Medipha Santé enable it to handle all the regulatory operations inherent in the distribution of medicines in France. The company thus acts as a privileged interlocutor of the health authorities. Very aware of the challenges and needs of a changing market, Medipha Santé ensures continuity of supply, thanks to the close links it has established with its suppliers, but also with its customers by anticipating their needs. More concretely, Medipha Santé's services are illustrated in several key areas:
- Regulatory affairs: the response to the registration needs of drugs or active substances. Medipha Santé handles the application for marketing authorisation (MA), its proper follow-up, price/reimbursement applications, eCTD or assistance with medical device files or the translation of files.
- Pharmacovigilance: handling the pharmacovigilance aspect requires a high level of scientific, pharmaceutical and medical expertise, both nationally and internationally. National coverage by a person in charge of pharmacovigilance, who is responsible, among other things, for monitoring the local scientific and medical literature, but also at European level, via a person qualified in the relationship with the European Medicines Agency (EMA).
- Launch and “exploitation”: whether on its own behalf or on behalf of its client, Medipha Santé manages this phase of the process in France as well as in several European markets. From the preliminary market study to the delivery of the products to hospitals or pharmacies, the company has integrated expertise in all distribution channels (tenders, wholesalers, pharmacies).
- European network: For 10 years, Medipha Santé has been part of a hive of consultants (EUDRACON) specialized in regulatory affairs and pharmacovigilance.
A commitment to confidentiality and qualityMedipha Santé is part of a demanding environment where confidentiality and personalised support are paramount. This operating laboratory gives French patients access to new, innovative medicines that meet the current challenges facing society, but also to the latest innovations in the pharmaceutical sector. With this in mind, Medipha Santé has signed an exclusive partnership with the company VeggiePharm. The latter markets 100% vegan medicines and food supplements that are aimed at both vegan patients and patients who are concerned about the animal cause. The company also accompanies new generation experimental treatments on the French market. Medipha Santé is a human-sized company with a proven track record. Pursuing its development while preserving the respect of ethical values, flexibility and quality of service is also one of Medipha Santé's priorities. With the main objective of defending the interest of the French patient, the company tends to become the partner of choice for plural and qualitative pharmaceutical projects. Watch our video on Le Figaro website.
Tele-registration of the reference person for pharmacovigilance in France (RPV)
Article R. 5121-164 of the Public Health Code states that any company or organisation “exploiting” a medicinal product or a product mentioned in Article R. 5121-150 of the Public Health Code must have the services of a pharmacovigilance reference person (RPV) attached to the qualified person responsible for pharmacovigilance activities in Europe (EU QPPV). The reference person (RPV) must meet the following criteria: read more...
The impact of the SARS-CoV-2 coronavirus on professional training
The SARS-CoV-2 coronavirus crisis has brought to the forefront the richness of the work done by certain professions that are sometimes undervalued. Whereas a few weeks earlier, the growing importance of robots and their competition with humans had been questioned, humans suddenly returned to the forefront. Human beings need to be trained in their professional career, to consolidate their attainments, deepen their knowledge, learn new techniques, undertake a retraining. So many reasons to resort to vocational training! read more...
ANSM risk analysis questionnaire for pharmacovigilance (PV) inspections conducted in France
In July, ANSM (the French medicine safety Authority) sent a questionnaire to all pharmaceutical companies in France to help prioritize Pharmacovigilance inspections and a guide to facilitate their completion. This questionnaire is intended for operators concerned by the scope of ANSM Pharmacovigilance inspections, in particular all non-operating MA holders, all “exploitant” subsidiaries, all “exploitant” companies such as Medipha Santé, all MA holders marketing medicinal specialities in France from another country of the European Economic Area. read more...
Medipha Santé and neuromuscular blocking agents
They talked about us in TF1, le monde, l'Echo republicain of 03/04/2020 "400,000 vials of neuromuscular blocking agents (curare) are delivered to hospitals in one weekend. . . Interview with Luc Lamirault, CEO of Medipha Santé : "Among the products we market, we have three generic references of curare (neuromuscular blocking agents)-curare based drugs used in intensive care units and for anesthesia during surgery. These are Rocuronium, Cisatracurium and Atracurium. Thanks to our stock, we have been able to deliver to 150 hospitals and clinics. They received 400,000 ampoules. We launched read more...
Medipha at CPhI 2019
We were there for you ! At Messe Frankfurt from Tuesday, November 5 to Thursday, November 7 2019 in Germany : CPhI Worldwide. It takes place once a year in different places in the World (Medipha Santé has been present over 5 times in the last decade!). This congress, founded in 1990, is an international exhibition of chemistry and pharmacy that today represents one of the largest pharmaceutical trade shows in the world. Source solutions from suppliers read more...
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
- November 2017: Amsterdam, the Netherlands, has been selected as new location for the European Medicines Agency (EMA).
- 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.