EU Annex 21: Importation of Medicinal Products

Description

EU Annex 21 – Importation of Medicinal Products

As of August 2022, compliance with the EU Annex 21 (Eudralex) requirements is now mandatory for organisations importing intermediates & medicinal products into the European Union and European Economic Area.

EU Annex 21 in the EU-GMP Guidelines describe the principles and requirements that apply to entities importing medicinal products (for human or veterinary use) across EU/EEA borders.

• 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
• EU Annex 21 has been in effect as of 22 August 2022

Applicability of EU Annex 21

EU Annex 21 applies to the importation of medicinal products into the EU/EEA, including bulk products, intermediates, and finished products.

Overview of EU Annex 21

The EU Annex 21 requirements apply 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 of EU Annex 21

When was the EU Annex 21 added 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).

Who must comply with EU Annex 21 (Eudralex) requirements?

EU Annex 21 GMP guidelines apply to manufacturers, importers and other entities 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 EU Annex 21 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 will need a Manufacturing Import Authorisation (MIA) to import products into the EU/EEA
  • You must comply with the GMP guidelines in EU Annex 21 as of 22 August 2022

EU Annex 21 GMP Rules for Importing Medicinal Products into the EU/EEA

• Learn the GMP requirements outlined in this EU Annex via this self-paced, online training course – available fully online with 24/7 access for 12 months
• This course is best suited for use in a blended GMP-compliance training program that includes site-specific training, product-specific training, and other GMP compliance expectations and standards
• To order, scroll up and add to your cart (one user per licence) along with other relevant courses, and complete your purchase
• Look into the training ‘bundles’ for ordering multiple GMP certificate courses
• Once you complete your order, check your emails for your log-in information (search all folders for “Annex 21” or for “onlinegmptraining.com”)

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EU GMP Guide – Compliance Training for EU Annex 21

This online training course covers EU GMP rules for importing medicines into the European Union (EU) and European Economic Area (EEA).

Who should complete this EU Annex 21 GMP requirements course?

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).

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/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 EU Annex 21 course will benefit the following entities:

• 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), including organisations from the UK, 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
• Quality Management Teams
• Other importers of bulk products, intermediates and finished pharmaceuticals into the EU/EEA

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This is a GMP Training Certificate Course.

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Course topics: EU Annex 21: Importation of Medicinal Products.

Topics detailed in this certificate GMP compliance training course include:

• Which organisations need to comply with the EU ANNEX 21 (and in effect date/s)
• Marketing Authorisation Holder (MAH) or Sponsor responsibilities for compliance with EU Annex 21
• Manufacturing Import Authorisation (MIA)
• What EU Annex 21 means for pharmaceutical manufacturers/importers involved in EU/EEA markets   
• Quarantine requirements for imported medicinal products
• Requirement for written agreements between sites involved with importation activities and/or certification (e.g., for multi-site importers/manufacturers)
• Documentation requirements for Qualified Person’s certification or confirmation
• Pharmaceutical Quality System (PQS) 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.

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Benefits of an online course for EU Annex 21 (Certificate GMP Training)

Manufacturers in the UK and others importing medicines 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. Online GMP training including this course:

• Are convenient and affordable
• Are available in an online, self-paced format
• Upon ordering a course, the training content can be conveniently accessed 24/7 via the internet
• Once a learner successfully completes the Final Assessment (within the online course), they will gain a Certificate of Completion that meets GMP requirements
• 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 (one user per licence)

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 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 in relation to 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

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

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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

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.

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Learn about the EU GMP guidance in Annex 21

This fully online Certificate GMP training course is suitable for a global audience and for various types of regulated products being imported into the EU/EEA for further processing and/or distribution in those regions.

To order this Annex 21 training presentation (prices are in US dollars), scroll up and “add to cart”. Complete your purchase, then check your email system for an email with your login details (search all mailboxes).

Purchase this course online, and start your training today! Be sure to read the GMP eLearning FAQs so you know what to expect.

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Other EU GMP regulations & guidance

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.

 Resources 

• • Download link for EudraLex – Volume 4
  • Download link for EU Annex 21 – Importation of Medicinal Products into the EU or EEA 
  • https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en

Other GMP training courses

With GMP eLearning, you can mix and match GMP education courses withing 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.

There are also face-to-face GMP courses available and GMP training delivered via Zoom.

Note: All course prices are in US dollars.

GMP Credentials & Certificates

• 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

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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.