Pharmacovigilance Services
M.P.C.A. International BV offers end to end pharmacovigilance services right from case intake to safety risk management. We bring together diverse talent groups and best in class database to deliver high end PV services. We have in house experienced and skilled medical professionals with first-hand knowledge of regulatory requirements.
Our Capabilities:
- Consultancy services to develop regional PV systems
- ICSR Case processing (DE, QC and MR): Safety Data Management, CIOMS reporting by EudraVigilance web trader or gateway use adapting to databank used by MAH.
- Literature Management: Global and Local (BENELUX) search and screening
- Weekly Global literature monitoring by search & screening
- Weekly Local literature monitoring by search & screening in BENELUX territory covered on local level
- Aggregate Reports (PADER, PSUR, DSUR): RA for PV: Life Cycle Management, Line Listing & Summary Tabulation, Renewals, PSUR/ PBRER medical writing, Safety and Regulatory Affairs e-submission of variations via eCTD (Extedo) or NeeS.
- Signal & Risk Management: Safety Risk Management: Signal Data management, Risk Management Plans and Benefit Risk Assessment.
- Excellent communication skills in English, French, Dutch and German.
Regional Requirements & Consulting Services:
- EU QPPV and Deputy QPPV.
- Local Contact Person in BENELUX and Deputy Local Contact Person in BENELUX.
- Safety Data Exchange Agreement (SDEA).
- Safety Physician Services and medically trained person.
- EudraVigilance Account development for MAHs with M.P.C.A. International BV as Third-Party Service Provider.
- XEVMPD management and update.
- Preparation and maintenance of PSMF/PSSF preparation: Implementation of Good Pharmacovigilance Practice Guidelines and development of PV Quality handbook: PSMF & Summary of the PV system, SOPs, Documentation, Forms, Instructions.
- PSUR Repository EMA with local M.P.C.A. International BV account or MAH account.
Quality Assurance & Support: QA for PV
- Develop Quality Management system.
- Audit of Pharmacovigilance System, QA for PV: Audit readiness support.
- Training and training compliance Management: PV and AE Awareness, SOP training, CIOMS reporting, XEVMPD, Auditing, …
Within our companies philosophy to bring quality, integrity and flexibility we serve our customers assuring at all times to stick to our commitment of providing Quality and Economy, which has been the key to cater our clients over the past growth period of our company.
e-CTD is mandatory
Since 5th May 2017 eCTD format became mandatory for New Drug Applications (NDAs), Abbreviated NDAs (ANDAs) and Biologics License Applications (BLAs).
The Electronic Common Technical Document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator, such as the USFDA or EMA.
The current version of the eCTD specification to be used for CTD modules 2-5 is the Electronic Common Technical Document Specification V3. 2.2.
M.P.C.A. International BV offers CTD to eCTD conversion and subsequent submissions in eCTD format or NeeS format (Non eCTD electronic Submissions). For eCTD we use the eCTD Manager tools of Extedo.
eCTD, VET eSubmissions and NeeS Applications by M.P.C.A. International BV
eCTD is a CTD or common technical document in electronic format. Abbreviated as eCTD.
The Common Technical Document (CTD) describes the organisation of modules, sections and documents to be used by an Applicant for a Marketing Authorisation for a medicinal product for human use agreed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The electronic Common technical Document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator.
While the table of content is consistent with the harmonised CTD, the eCTD also provides a harmonised technical solution to implementing the CTD electronically. In other words, an eCTD is the submission of PDF documents, stored in the eCTD directory structure, accessed through the XML backbone and with the files integrity guaranteed by the MD5 Checksum.
The eCTD format is mandatory to be used for all submission types related to Marketing Authorisation for products within all EU procedures (i.e. Centralised, Decentralised and Mutual Recognition Procedures). In accordance with the eSubmission Roadmap, mandatory eCTD format is also stepwise introduced for National Procedures.
VET eSubmissions
The Veterinary Harmonisation Group (VHG) is a subgroup of the eSubmission expert group and is made up of representatives from National Competent Authorities, the EMA and Industry. Its objective is to develop and implement standards for the submission of electronic information in the context of European veterinary medicines approval procedures.
NeeS or Non eCTD electronic Submission
eCTD is mandatory however there are a small number of exceptions where NeeS submission is still possible.
For more information about our way of working, timelines and prices, please contact us at info@mpca.be.
New Packaging Instructions in Luxembourg
Written on March 3, 2023
End of January 2023, the Luxembourg authorities updated their document ‘Procedure for marketing authorisation applications in Luxembourg’: the version 3 was published on their website on January 20th 2023 (a new tab was created in the excel file with information regarding the Product information). Source: Procédures au Luxembourg - Portail Santé - Luxembourg (public.lu).
MAHs have now to indicate the MA number(s) and/or the paragraph on the reporting of adverse reactions on the product information (SmPC, labelling and PIL, respectively) of medicinal products distributed from Belgium/France/Germany and intended for Luxembourg market.
It is a new requirement that the LU authorisation numbers need to be included in the product information.
Apparently, the Belgian FAMHP and the Luxembourgian DPM accept that the change of the product information can be carried out via an editorial change, at the time of a next submitted variation with impact on the product information.
However, the following conditions must be met:
- The change must be clearly indicated in the application form of the variation (scope and present and proposed) and in the cover letter.
- The implementation period is one year from January 21st, 2023; this change can also be submitted separately as a variation of type IA C.I.Z..
After the one-year implementation period, these changes will be considered as IA C.I.Z. variations.
The exact template to use for the SmPC, labelling, and PIL can be found in tab 2 of the Excel sheet.
M.P.C.A. International BV can estimate the work that needs to be done to bring your marketing authorisations up to date.
We can brainstorm together and develop a retro planning communicating well with your Supply Chain to avoid the cost of destroying leaflets.
Please do not hesitate to contact us for any further information or assistance.
Medical samples
Don’t forget the sample management communication to the FAMHP in Belgium before March 1st, 2023, for all samples delivered within the last calendar year 2022.
The delivery of free medicinal product samples by pharmaceutical companies, which is also a form of advertising, is regulated.
The marketing authorization holder can deliver samples, exceptionally, only to persons authorized to prescribe medicinal products and on their personal demand.
The maximum number of samples that can be awarded is limited to 8 per medicinal product, per calendar year and per person authorized to prescribe medicinal products.
The marketing authorization holder must have an adequate system for controlling the distribution of samples, under the responsibility of the responsible person for information and publicity (RIP).
This is described in the Belgian Royal Decree of 11 January 1993 establishing the conditions under which the delivery of medicinal products for human use as samples can be performed, and Circularly Letter n° 503.
For all practical information concerning medicinal samples please contact M.P.C.A. International BV.
Life Cycle Management: from birth date and for always a healthy and happy life!
We hold extensive experience in building a long-term high-quality, honest and flexible relationship with our clients, the marketing authorisation holders, to provide ongoing and continuing life cycle management for their medicinal drugs on the market.
A medicinal drug product is available to patients as from the first day of market access and can remain on the market for decades. From birth date to first market approval through product innovations such as new indications, formulations, line extensions, etc… each and every milestone in that lifecycle will be shaped and challenged by regulatory requirements.
A dedicated and pro-active regulatory affairs department is crucial during the lifecycle of a medicinal drug and should be included in the marketing authorisation holders’ lifecycle planning strategy.
In other words, regulators must act as a checkpoint at every critical milestone on the product journey. When companies build regulatory strategy into the product’s lifecycle plan, they can optimise value, reduce risk, control costs and ensure compliance.
Such long-term planning is common among the largest pharmaceutical companies where dedicated teams are on hand daily, but small and medium sized companies may lack the experience, expertise or resources to develop a comprehensive regulatory affairs strategy that can evolve with the product. This unplanned approach can create unexpected delays and potentially derail the long-term revenue potential of the product.
Such losses can be avoided when companies think through the product lifecycle during development to identify the regulatory expectations at every key milestone. This can help them proactively capture relevant safety and efficacy data to meet future global and local requirements.
When companies build regulatory strategy into the product's lifecycle plan, they can optimise value, reduce risk, control costs and ensure compliance.
Remember: good quality is mandatory, poor quality or lack thereof only leads to problems in the short- or long-term.