EU Annex 21: Importation of Medicinal Products
Course duration: Allow 1.5 to 2 hours to complete this course.
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EU Annex 21 – Importation of Medicinal Products
EU Annex 21 (Eudralex) compliance is now mandatory for organisations importing medicinal products into the European Union and European Economic Area.
- EU Annex 21 is a relatively new addition to the EudraLex (Volume 4)
- This Annex covers GMP requirements for medicinal products being imported into the EU or EEA from non-EU and non-EEA member states/countries
- The effective date/operational date for compliance with EU Annex 21 is 22 August 2022
Applicability of EU Annex 21
EU Annex 21 applies to the importation of medicinal products into the EU/EEA
This Annex applies to all imported medicinal products intended for:
- Human use
- Veterinary use
- Investigational purposes (investigational medicines/IMPs)
This EU Annex is applicable to products that are physically imported into the EU or EEA for further processing (e.g. bulk products, intermediate products), and to finished pharmaceuticals/medicinal products intended for distribution in the EU/EEA.
Other EU GMP GUIDE requirements apply as described in other Chapters and Annexes of the EudraLex (Volume 4).
Conditions of the Marketing Authorisation (MA) or Clinical Trial Authorisation(CTA) must also be met.
EudraLex Volume 4: EU Annex 21 – Importation of Medicinal Products
Background to the addition of EU Annex 21 to the EudraLex (Volume 4)
European Union (EU) Annex 21 of the EU GMP Guide was first published in the EudraLex (Volume 4) on 16 February 2022. Compliance with EU Annex 21 GMP requirements is now a legal requirement for manufacturers (MAH)/importers of medicinal products; effective as of 22 August 2022.
Overview of EU Annex 21
EU Annex 21 GMP guidelines apply to manufacturers and importers who import finished pharmaceuticals, bulk products and/or intermediate products into the European Union/European Economic Area (EU/EEA). This includes products imported for further processing (bulk products, intermediates) as well as products imported for distribution in the EA/EEU.
- This Annex is also applicable to Investigational Medicinal Products (IMPs).
- Exclusions: Imported medicinal products that originate from other EU/EEA states.
Why it’s important to complete this EU Annex 21 training course (online):
- EU Annex 21 GMP guidelines are now operational (mandatory)
- Regulatory audits (e.g., by the EMA) will refer to this Annex and other relevant EudraLex Chapters and Annexes
- If you are involved with any form of importation of medicines into the EU/EEA, intended for human use, veterinary use or investigational purposes:
- You must comply with the GMP guidelines in EU Annex 21 as of 22 August 2022
- You will need a Manufacturing Import Authorisation (MIA) to import products into the EU/EEA
- Find out what’s involved to comply with the GMP requirements outlined in this EU Annex in this self-paced training course
- Available fully online, with 24/7 access for 12 months
- Best suited for use in a blended GMP compliance training program that includes site-specific/product-specific training
- To order, simply scroll up and add to your cart, along with other relevant courses, and complete your purchase
- Then check your emails for your log-in information (search all folders for “Annex 21”)
EU GMP Guide – Compliance Training for EU Annex 21
This online training course covers EU GMP requirements for the importation of medicines into the European Union and EEA.
Compliance with EU GMP regulations, including EU Annex 21 GMP requirements for importing medicines into the EU/EEA, should be completed by:
- Marketing Authorisation Holders (MAHs) and Sponsors
- Organisations inside the EU/EEA that have a Manufacturing Import Authorisation (MIA)
- Importers bringing products into the EU/EEA from non-EEA member states
- Other entities/QPs involved with the importation of finished products (and/or bulk products or intermediate products for further manufacturing and/or distribution) in the EU
- Third-country manufacturers
- Organisations outside of the European Economic Area (EEA) that plan to:
- Import medicinal products into the European Union or European Economic Area
- Including manufacturers/exporters in the UK, which left the European Union & must now comply with EU GMP ANNEX 21 for importing medicines
- GMP compliance Inspectors/Auditors
GMP Certificate Course
EU Annex 21: Importation of Medicinal Products.
Topics detailed in this certificate GMP compliance training course, covering the importation of pharmaceuticals/medicinal products into the EU/EEA (as described in EU Annex 21 and relevant EudraLex documentation), include:
- Which organisations need to comply with the EU ANNEX 21
- The effective date for compliance with EU Annex 21
- What EU Annex 21 means for pharmaceutical manufacturers/importers involved in EU/EEA markets
- Marketing Authorisation Holder (MAH) or Sponsor responsibilities
- Manufacturing Import Authorisation (MIA)
- Quarantine requirements for imported medicinal products
- Requirement for written agreements between sites involved with importation activities and/or certification
- Documentation requirements for QP certification or confirmation
- Pharmaceutical Quality System requirements for involved organisations
- Other relevant GMP compliance requirements
To order this course, scroll up and click ‘add to cart’, then complete the checkout process.
Benefits of completing this EU Annex 21 certificate training course (online)
As of 22 August 2022, manufacturers in the UK need to comply with the EU GMP Guide – including complying with EU Annex 21 – when importing, processing, and/or distributing medicines from the UK into the EU/EEA.
- This EU GMP education course is suitable for any business that manufactures, services, imports/exports and/or distributes a medicinal product in the European Union or European Economic Area (EU/EEA)
- It’s available in an online, self-paced format
- Upon ordering the course, the training content can be conveniently accessed 24/7 via the internet
- Once a learner passes the Final Assessment (included in this online course), they will gain a Certificate of Completion
- This Certificate can be added to the employee/suppliers training program file and is essential for future audits of GMP compliance
- The training material can be reviewed for 12 months from the date of purchase
EU Annex 21 eLearning
Note about our online GMP compliance training:
- This course is best combined with onsite training & product-specific training, in a blended learning program.
- It is NOT intended to replace training related to:
- Onsite product training and site-specific training
- Reading/understanding the guidance provided in the Eudralex Volume 4 in relation to the importation of medicinal products into the EU/EEA
- Other GMP requirements as in the EU GMP Guide
- Training for compliance with terms and conditions in the Marketing Authorisation or Clinical Trial Authorisation
Other Eudralex Chapters and Annexes
In addition to EU Annex 21 guidance, learners should complete other necessary training to comply with EudraLex/EU GMP guidelines relevant to:
- Product classification(s) for imported products
- Distribution regions/jurisdictions
- Manufacturing Authorisation (MA) or Clinical Trial Authorisation (CTA)
- Manufacturing Import Authorisation (MIA)
- Pharmaceutical Quality System (PQS)
- Other responsibilities agreed to or required by the Regulatory Authority in the jurisdiction of importation, manufacturing and/or product distribution
EU Annex 21 – terms and definitions (acronyms)
- EU = European Commission
- EEA = European Economic Area
- EEA Member State = 27 EU countries plus 3 additional member states
- MAH = Marketing Authorisation Holder
- MIA = Manufacturing Import Authorisation
- EMA = Europeans Medicines Agency
- Importation = physical importation
- QP = Qualified Person (the person responsible for certification or confirmation of products)
EU GMP guidance for pharmaceutical manufacturers
Benefits of online training
Completing this Certificate GMP training course in EU Annex 21 regulatory requirements will help you and your manufacturing and distribution teams learn what’s generally expected by the EMA/EU/EC in terms of importation of pharmaceutical products and other medicinal products into the European Union/European Economic Area (EU/EEA).
This online GMP training course will answer common FAQs about EU Annex 21 requirements, including compliance requirements for UK-based manufacturers seeking to import pharmaceutical products, bulk or intermediate products into the European Union.
Learn about the EU GMP guidance in Annex 21
This fully online Certificate GMP training course is suitable for a global audience and for any type of regulated products being imported into the EU/EEA for further processing and/or distribution in those regions (member states).
To order this Annex 21 training presentation (prices are in US dollars), simply scroll up and “add to cart”, complete your purchase, and then check your email system for an email with your log-in details (search all mailboxes).
Purchase this course online, and start your training today! Be sure to read the FAQs so you know what to expect.
EU GMP regulations and guidance
This training course is suitable for a worldwide audience.
This certificate Annex 21 training course for product imports into the EU/EEA is ideally suited for:
- Qualified Person (QP)
- Business Owners and Operations Managers
- Industry Service Providers and Software Support personnel/contractors
- Pharmaceutical Quality Managers and Medical Device Industry personnel
- Medical device manufacturing personnel
- Production Managers
- Quality Managers and Quality Assurance teams
- Design engineers and device maintenance personnel and/or device quality testing managers
- Auditors and GMP Compliance Inspectors
- Quality Team Leaders and Quality Management Associates
- Post-Marketing Surveillance Personnel or contractors
- Packaging and Labelling Operators and Logistics Managers
- Other personnel working in a GMP/cGMP environment
This newly-released EU Annex 21 presentation is ideal to complete along with the Annex 16 (Authorised Person and Batch Release), Complaints Management course, the Deviations and Non-Conformances management course, and the CAPA systems training course.
GMP industry and EU GMP compliance training experts
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).
- This is one of our many GMP education topics eLearning courses available 24/7.
- It is a follow-up course to the other standards training course(s) listed previously, as well as being a suitable follow-up training course to our Complaints Management courses and CAPA training courses for GMP personnel and Managers.
- This self-paced, online EU GMP – ANNEX 21 training course covers regulatory requirements for importing medicines/medicinal products into the EU
- It is suitable for a wide range of personnel
- Download link for EudraLex – Volume 4
- Download link for EU Annex 21 – Importation of Medicinal Products into the EU or EEA
Other GMP training courses
Click here for a list of face-to-face courses delivered via Zoom (onsite training of large groups of personnel may also be available, where feasible).
With online training in EU GMP Guide regulations such as Annex 21; product recalls, CAPA implementation and other GMP education topics, you can mix and match GMP education courses with a training bundle package.
Alternatively, you can purchase a single course or just a few of the courses you need for just-in-time learning.
- Note: one learner, one cGMP course completion Certificate per course purchase.
- The learner will have 12 months’ access to the course and a downloadable online EU Annex 21 training Certificate of Completion.
Note: All course prices are in US dollars.
Bundled training options let you ‘mix and match’ standard GMP compliance training courses and/or assign courses to different employees when required (enabling ‘just in time’ GMP training). All successfully completed courses provide learners with a time-dated GMP Training Certificate for successful completion of that particular GMP education topic.
About this Pharmaceutical Industry training course
- Completion of any of our online GMP courses will enable you to print your GMP topic Course Certificate — and earn a Credly badge for your social media channels.
- You can also attach your Certificate of Completion to your CV when applying for jobs in the pharmaceutical sector.
Best-practice GMP compliance training programs use a blended learning plan.
- Review other top-ranked GMP courses and best-practice GMP training courses
- Or contact us for information on training large groups of employees and/or for Zoom-delivered courses
How to complete this course.
- Add the course to your basket and complete your purchase.
- Remember, the course fees are listed in US Dollars.
- Check your emails (all folders) for log-in instructions approximately 5 to 10 minutes after your order is finalised.
- Be sure to search for/add the following domains to your safe sender’s list: “@onlinegmptraining.com” and @pharmout.net”.
One user/per licence purchase (12 months’ access)
- This GMP education topic is available online, one user per licence.
- Course completion provides learners with a foundational understanding of GMP requirements relating to importing medicinal products into the EU/EEA including PQS requirements, documentation requirements, written agreements with suppliers/importers, responsibilities of the Marketing Authorisation Holder (MAH) and Manufacturing Import Authorisation holder (MIA), third-country manufacturers, etc.
Allow 1.5 to 2 hours to complete this EU Annex 21 eLearning training course including the online Final Assessment.
Further Reading: Pharmaceutical Industry Resources
Recommended training courses to ensure compliance with EU Annex 21 and other medical device standards and regulations include the following GMP education courses.
CAPA training presentation (live-streamed)
Deviations and Non-Conformances (Management) in cGMP environments
Complaints Handling and Recalls (available now)
Back to the online GMP training store.
Explore Pharmaceutical/biological manufacturing industry induction training modules.
Explore our GMP training bundles and discounted options (mix and match.
Europeans Medicine Agency (EMA)
Are your SOPs for deviation management out of date?
- Click here for Deviation Management examples and templates.
- Technical writers for SOPs are also available as PQS/QMS consultants/writers.