The EU Annex 21 outlines current Good Manufacturing Practice (cGMP) requirements for medicinal products imported from non-EU/EEA countries. It applies to bulk products, intermediates, and finished medicinal products intended for human, veterinary, or investigational use. Organizations importing intermediates and medicinal products into the European Union (EU) and European Economic Area (EEA) must comply with cGMP regulations in EU Annex 21.
Compliance with EU Annex 21 requirements published in EudraLex Volume 4 is mandatory for all companies who import medicinal products/substances into the EU and EEA.
Learn the essentials of EU Annex 21 compliance in PharmOut’s Certificate cGMP Training Course.
Key Learning Topicsย
This online training course covers the key cGMP requirements outlined in EU Annex 21 (in effect since 2022), including:
๐ Which entities are required to comply with the latest EU Annex 21 requirements ๐ Responsibilities of Marketing Authorisation Holders (MAHs) and Sponsors ๐ Requirements for Manufacturing Import Authorisation (MIA) ๐ GMP obligations for manufacturers and importers in the EU/EEA ๐ Quarantine requirements for imported medicinal products ๐ Written agreements between importation and certification sites ๐ Qualified Person (QP) certification (documentation requirements) ๐ Pharmaceutical Quality System (PQS) obligations ๐ Other cGMP compliance requirements
Benefits of cGMP Training Completion
EudraLex Volume 4: Learn Annex 21 guidance on cGMP requirements. Regulatory Updates: Stay compliant with evolving EU GMP guidelines. Training Materials: Includes industry best practices and compliance strategies. Certificate of Completion: Verifiable proof of training for regulatory audits.
GMP Credentials & Certificates
Completion of our online cGMP courses provides you with a Certificate of Completion for that course title.
Who Should Complete This EU Annex 21 Compliance Training Course?
This online training course is suitable for professionals involved with medicinal product importation, manufacture and distribution in the EU/EEA region, including:
โ ย Qualified Persons (QPs)
โ ย Business Owners and Operations Managers
โ ย Pharmaceutical Quality Managers and GMP Compliance Teams
โ ย Medical Device Industry Professionals
โ ย Production and Quality Managers
โ ย Design Engineers and Device Maintenance Personnel
โ ย Auditors, GMP Compliance Inspectors
โ ย Regulatory Affairs Professionals
โ Site Inspectors/Auditors
โ ย Packaging, Labelling, and Logistics Managers
โ ย Marketing Authorisation Holders (MAHs), Sponsors, and MIA Holders
โ Third-Country Manufacturers
โ UK-based exporters to the EU/EEA
Enhance your EU Annex 21 knowledge
Learn the Essentials of EU Annex 21 Compliance including the following concepts:
๐ EU cGMP Guide (EudraLex Volume 4): EU Annex 21 cGMP rules for importation. ๐Marketing Authorisation (MA) or Clinical Trial Authorisation (CTA): Authorisation conditions.
๐Manufacturing Import Authorisation (MIA): Required for importation into the EU/EEA.
๐Qualified Person (QP) Certification: Ensures compliance with GMP standards before distribution.
๐Pharmaceutical Quality System (PQS): Required for all importation activities.
Flexible Online Learning Options
Thisย self-paced eLearning course allows participants to:
โ๏ธ Access training materials 24/7 for 12 months โ๏ธ Complete the training at their own paceย with practical case studies โ๏ธ Combine online learning with instructor-led training options (virtual or onsite, where available) โ๏ธ Order GMP Compliance Training Bundles: Multiple courses available, save $ by purchasing 4 or more courses and large-group bundles. โ๏ธ Global Accessibility: Suitable for a worldwide audience so you can train your team across multiple jurisdictions and multi-site locations
Note: All course prices are in US dollars.
cGMP Training Certificate for EU Annex 21
The course provides learners with a helpful training resource relating to internationally accepted standards and regulatory guidance for importing medicinal products/pharmaceutical products into European Union member states and additional countries that are linked with the European Economic Area (EEA).
Important: Learners should download and review the EU Annex 21 regulations in addition to completing this course.
โ๏ธ Recommended approach: Read the regulations before and after the training course to enhance knowledge retention. โ๏ธ Blended Learning Approach: cGMP eLearning is best combined with onsite training, product-specific training and other relevant courses.
Proof of cGMP Training
โ Upon successful completion of this eLearning course, learners will receive an EU Annex 21 cGMP Training Certificate of Completion. โ ย This cGMP Certificate of Completion can be used to demonstrate compliance training. โ ย It should be attached to personnel records and applications for promotions or new jobs in the medical products/pharmaceuticals and pharmaceutical shipping/logistics planning sectors.
โ ย The certificate validates an individualโs knowledge of EU Annex 21 regulatory expectations and best practices.
Recommended Blended-Learning Approach
Online courses are an affordable and convenient way to complete cGMP training or to train your entire team.
Best practices for cGMP Training rely on blended learning solutions, along with appropriate Supervision, onsite support, and practical training led by the site’s training teams and/or Supervisors.
We recommend that you (or your learners) review the relevant EU cGMP regulations and related standards both before and after completing this course to aid knowledge retention and promote a ‘compliance culture’.
This course is best combined with onsite training & product-specific training, in a blended learning program.
It is NOT intended to replace Supervision and other necessary training topics including onsite training, site-specific training, etc.
It can aid personnel retention of compliance data but does not replace:
Reading and understanding the guidance provided in the Eudralex Volume 4 covering the importation of medicinal products into the EU/EEA
Other GMP requirements as in the EU GMP Guide
Site-specific training and product-specific training to comply with the terms and conditions in the Marketing Authorisation or Clinical Trial Authorisation
ย
How to complete this course
Add the course to your basket and complete your purchase.
Course fees are listed in US Dollars
One user/per licence purchase (12 monthsโ access)
You can combine this course in a training bundle (search for the bundle tabs) if ordering multiple GMP courses
If you have a large group to train, contact us with a request for a quote (30 or more individuals)
Check your emails (all folders) for log-in instructions approximately 5 minutes after your order is finalised
Be sure to search for/add the following domains to your safe senderโs list: โ@onlinegmptraining.comโ and โ@pharmout.netโ
Review the content, answer the quizzes and final assessment, and click โback to courseโ to download your Certificate once completed
You donโt have to complete this course in one session
You can stop learning and resume your place as often as needed
You can access and review the entire course 24/7 for the 12-month licence period
Other Courses Relevant to Medicinal Product Importation
Along with the EU Annex 21 training, you and/or your team may want to complete the following online cGMP courses:
Need support? Contact PharmOut’s GMP consultants & validation experts.
Visit https://pharmout.net for details or to request regulatory compliance support or onsite training for your team (subject to scheduling availability). We can provide documentation and SOP writing experts, GMP process and equipment validation experts, serialisation project managers, and more!
With GMP eLearning, you can mix and match GMP education courses within training bundles/GMP training packages. Alternatively, you can purchase a single course or just a few of the courses you need for just-in-time learning.
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