The European Directorate for the Quality of Medicines & HealthCare (EDQM) are currently implementing a “new-look” CEP (Certificate of Suitability). This is following a public consultation with stakeholders which in turn led to the launch of the project CEP 2.0.
The aim of the project was to provide greater transparency and reduce the regulatory burden.
The EDQM has outlined 9 specific areas (listed below) which will be affected by the implementation of CEP 2.0:
Area 1: CEPs and information reported
Area 2: Changes regarding assessment of CEP applications
Area 3: On-line public certification database
Area 4: Authorities database
Area 5: Fostering information sharing between CEP holders & MAH
Area 6: Reduction of revisions of CEPs
Area 7: Impact of changes and their implementation
Area 8: Trainings for CEP holders and CEP users
Area 9: Revising documents available on the EDQM website
Further details about each area is provided on the EDQM website here, under the heading ‘CEP 2.0 – What will change?’.
The layout of the “new look” CEP will be similar to the current one but the main changes to the information that will be reported on CEPs going forward are:
Numbering system will no longer include renewal number at the start i.e. R0CEP YEAR-123-Rev 05
The CEP holder’s name and address & all sites listed on CEP will now include the EMA SPOR/OMS Organisation (Org) and Location (Loc) ID.
Information reported on the CEP for chemical purity, Herbal Drug/Herbal Drug preparations and related to the quality of the substance will be revised, for example:
The approved specification (as in the section 3.2.S.4.1) and certain analytical methods, will be appended to the CEP
The quality of water (i.e. purified water, distilled etc) used in the last steps of synthesis will be reported on CEP.
No declaration of access box will be in the CEP document anymore (will be replaced by a letter of access from the CEP holder).
Also, it will be issued as an electronic document with a digital signature (No more paper copies).
The implemention of CEP 2.0 started on 1st of September 2023.
There will now be a coexistence of “new look”, “hybrid look” and “old look” CEPs for some time:
From 1st 2023, “new look” CEPs (as outlined above) are being issued for new CEPs granted and following renewal procedures.
A “hybrid look” CEP will be granted after a revision of an existing CEP when the content of the CEP is impacted, but the company’s specifications will not be appended to the CEP (since this may require additional assessment not linked to the request for revision). The “hybrid look” CEP will have the new numbering, SPOR/OMS Loc ID, the declaration of access removed and will be issued as an electronic document with an e-signature.
“Old look” CEPs will continue to be valid until they need to be revised.
The webinar is for CEP applicants, holders and users, including manufacturers and competent authorities. The webinar provides an overview of the changes and outlines the revised evalution procedures (new applications, revisions, renewals) for CEP applicants and CEP holders.
If you need assistance with anything CEP related, get in touch with us at info@eureg.ie
Written by
Claire Brown
https://eureg.ie/wp-content/uploads/2023/12/edqm.png225225ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2023-12-06 15:12:052023-12-07 11:58:12CEP 2.0 – A “new-look” CEP is here
In accordance with comma 1 of art. 122 of Legislative Decree 219/2006 of Italian law it is a mandatory requirement to notify AIFA with a list of pharmaceutical sales representatives employed during the previous year. This includes the qualification and type of employment contract they have with the Pharmaceutical company.
The deadline is fixed at 31 January of every year.
Although the AIFA communication regarding the lists of pharmaceutical sales representatives for the year 2021 has not been published by AIFA yet, we would like to remind you that this must still be complied with.
Should you need any support to meet this obligation just contact us and the Ivowen team are here to help.
Written By
Alice D’Alton
https://eureg.ie/wp-content/uploads/2020/02/time-for-action-clock-recd-28-02-20-scaled.jpg22882560ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2022-01-13 11:01:572023-11-06 11:15:43AIFA – Remember to submit your list of pharmaceutical sales representatives for 2021
Are you an experienced Regulatory Affairs professional looking for a new challenge in a dynamic and fast-moving consultancy? Then we may be the fit for you. We are currently recruiting for
Exciting opportunities exist for the right people in a dynamic and focused regulatory affairs consultancy company in Clonmel, Co. Tipperary.
The main duties would include but are not be limited to:
preparing and compiling fully EU CTD compliant marketing authorisation applications (MAAs) using the DCP, MRP and CP procedures
preparing, compiling, publishing and maintaining eCTD lifecycles
preparing, compiling and submitting variations
preparing, compiling and submitting renewals
preparing, compiling and submitting clinical trial applications, etc.
writing and signing Quality Overall Summaries and Expert Statements
reviewing other MAAs for compliance to standards and preparing gap analyses for clients
providing strategic regulatory advice
keeping clients up to date with local national requirements
liaising with regulatory authorities on behalf of client companies as required and represent the client at regulatory authority meetings as required
provision of training courses in Regulatory Affairs
Other Responsibilities
Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Regulatory Affairs and Drug Development for pharmaceuticals for human and veterinary use. Medical Devices and/or Pharmacovigilance support is also a service provided and any knowledge or experience in this area would be useful. Staying up to date with changing regulatory requirements is expected. On-site placement at a client’s place of business may be required.
Skills/Experience
Minimum Life sciences degree (BSc or equivalent)
Minimum 1 – 2 years relevant experience in Regulatory Affairs is a prerequisite, with a minimum 1-2 years other relevant experience in the pharmaceutical sector such as QA/QC, Compliance, etc.
Medical Devices and/or Pharmacovigilance experience would also be very beneficial
Excellent working knowledge of EU and UK regulatory requirements and procedures required
Familiarity with electronic submissions (eCTD) useful but not a requirement
Candidates must be familiar with Adobe and MS Office, or equivalent, etc.
Excellent written and oral communication skills required, attention to detail and ability to handle multi-faceted projects at the same time a distinct advantage
Benefits package
Salary negotiable and commensurate with experience
Attractive benefits package
Flexible working hours and/or part-time position available
Working from both home and office available
Closing date
Please send all applications to jobs@eureg.ie with CV and cover letter outlining your relevant experience. Closing date 10/05/2021. Candidates will be contacted after this date.
REF: IVO-2020-04-01
NOTE – no recruitment agency approaches please.
https://eureg.ie/wp-content/uploads/2021/04/We-are-hiring-20-04-21-612x380-1.jpeg380612ivowenadminhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgivowenadmin2021-04-21 13:28:202023-11-06 11:18:24Ivowen is hiring
