Importation of Medicinal Products: Understanding the EU requirements

Importation of Medicinal Products: Understanding the EU requirements

The manufacturing of medicinal products for the EU market frequently occurs outside the EU zone and this presents logistics and regulatory considerations for the product owner. All stages of manufacturing medicinal products in third countries should be carried out in accordance with EU Good Manufacturing Practice (GMP) guidelines if the products are destined for the EU market. It is imperative to ensure that products are consistently manufactured and controlled according to quality standards.

This article outlines key considerations when importing medicinal products from outside the EU.


  1. Manufacturer/Importer Authorisation (MIA)

To import products into the EU, wholesale distributors receiving medicinal products from third countries must hold a Manufacturer/Importer Authorisation (MIA) for the site where QP certification and physical importation occur. MIA is also required if the location where batch certification is performed is different from the location where the imported product is physically received.

Importers are required to adhere to GMP standards as MIA holders, which include setting up a pharmaceutical quality system, having sufficient personnel and workspace for the relevant activities, planning appropriately for the handling of complaints and recalls, and putting protocols in place to manage their supply chains.

Following Chapter 7 of the EU GMP guidelines, a written agreement should be signed between the premises engaged in manufacturing and importation activities and the Marketing Authorisation Holder (MAH), and should set out the respective responsibilities of the MAH, the importer, the QP certification site and the third country manufacturer.


  1. Qualified Person (QP) Certification and Quality Control Testing of Imported Medicinal Products

Imported medicinal products must be physically imported and cleared through the customs territory of an EU country and then stored under quarantine upon receipt until released for QP certification. It is a legal requirement that the QP certify the batch to ensure that all medicinal products imported from third countries are manufactured under the EU GMP standards and that products will be tested when imported into the EU unless there is a Mutual Recognition Agreement (MRA) or Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA).

Full batch documentation must be provided to the MIA holder responsible for the QP certification of the batch to ensure continued product quality. (see Annex 21 of the EU GMP guidelines for details)

  • Relevant ordering and delivery documentation should be included in batch documentation, such as the details of transportation (e.g., temperature monitoring records).
  • If batches have been subdivided and individual quantities imported separately, documentation confirming quantity reconciliation should be provided at the QP certification site.
  • Details of the on-going stability programme, such as protocols, results and reports, should also be available for inspection at the QP certification site, as required in Chapter 6 of the EU GMP guidelines.

All documentation must be kept in compliance with the standards of Chapter 4 of the EU GMP Guidelines. Additionally, the certifying QP oversees making sure that reference and retention samples were obtained in compliance with relevant GMP for Investigational Medicinal Products (IMPs) guidelines as well as the criteria in Annex 19 of the EU GMP guidelines. Furthermore, all batches of medicinal products where a MRA is not present must undergo quality control testing in an EU based laboratory (e.g., a contract laboratory) to help ensure the quality and safety of the products entering the destination country.

The QP will certify the batch upon approval of the batch testing results listed below: (see Annex 16 of the EU GMP guidelines for details)

  • Quantitative and qualitative analysis of active ingredients and related medicine components. All the other tests or checks necessary to ensure the quality of medicinal products is in accordance with the requirements of the MA.


  1. Importer of Record (IoR)

During importation, an Importer of Record (IOR) in the destination country is required, as they are responsible for ensuring that the medical devices/goods are imported in accordance with the laws and regulations of the importing country. The following documents are example requirements:

  • Product Classification – details of the category and value of the imports.
  • Import and Export licenses – permission to import products.
  • Fees/Taxes/Duties – documents when paying related fees, taxes or duties.

In addition, the IOR also needs a valid Value Added Tax (VAT) number and a valid EU Economic Operator Registration and Identification (EORI) number, which can be applied to the local tax authorities (usually the EU country where the imported products will arrive) as an identification number for all customs procedures when exchanging information with the EU customs authorities.


Contact us today for further information on importation of medicinal products into the EU. HiTech Health holds Manufacturer’s/Importer’s Authorisations (MIAs) for the importation and QP certification of both Commercial and Clinical products within the EU. By partnering with us and working with our experienced cross-functional team under our already approved MIAs, you reduce personnel and regulatory cost, thereby making considerable financial and time savings in getting your product to the clinic or market. HiTech Health have a team of Qualified Persons (QPs) and Responsible Persons (RPs) available to support your product portfolio.


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PMTC Spotlight – HiTech Health

PMTC Spotlight – HiTech Health

HiTech Health is delighted to be selected as the ‘Spotlight’ company by the Pharmaceutical Manufacturing Technology Center (PMTC). Read the article in the PMTC Monthly Spotlight.


HiTech Health is a full-service Contract Development and Manufacturing Organisation (CDMO) in the cell and gene therapy space. We have added GMP Clean Rooms to our state-of-the-art laboratories in Galway, allowing for the manufacture of clinical materials. This adds significantly to existing capabilities which includes process, analytical development and supporting services.


Please email to request further information on the range of services HiTech Health can provide.

Good Distribution Practice (GDP): 3 Considerations for Ensuring Compliance

Good Distribution Practice (GDP): 3 Considerations for Ensuring Compliance

Ensuring product quality and integrity is maintained throughout the end-to-end supply chain of medicinal products is imperative. The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities necessary to ensure confidence that the product delivered maintains its quality and integrity and remains within the legal supply chain during storage and transportation. This means that the legal owner of the product must have full oversight and traceability of the product at all times during distribution, ensuring that falsified and counterfeit medicines do not enter the product supply network. Below are three key points to consider when seeking to comply with Good Distribution Practice (GDP).


  1. Are GDP Self-Inspections being performed?

Performing self-inspections to ensure your company is maintaining compliance with the latest GDP requirements can be beneficial. Self-inspections can support identifying gaps and areas that are higher risk in your supply chain. An internal team assigned with the task of performing GDP self-inspections can:

  • Critically review processes and procedures to check that the company is conducting supply chain activities in a GDP-compliant manner
  • Review CAPAs and ensure that they are implemented and closed
  • Examine records and agreements as well as procedures to ensure there are no deficiencies

Regular self-inspections can help foster a company culture of continuous improvement and compliance.


  1. Does your company perform Bona Fide Checks on Customers and Suppliers?

Bona fide checks, in simple terms, provide evidence that someone is who they say they are, or has the authority and experience they claim to have. Performing bona fide checks is an activity that can often be overlooked in the pharmaceutical industry but is essential for maintaining GDP compliance. Regulatory deficiencies may include:

  • No bona fide checks carried out at all
  • No verification that customers or suppliers are authorised to perform the operations that they are performing
  • The address of the customer or supplier has not been verified, or the wrong address is provided
  • Licences of the customers or suppliers not requested and reviewed. For example, a wholesaling partner who does not provide a copy of a Wholesale Distribution Authorisation (WDA) licence in the EU

Ensuring your company has a well defined procedure for performing bona fide checks and appropriately qualifying customers and suppliers can help ensure GDP compliance.


  1. Are company employees being effectively trained on GDP?

Personnel involved in the supply chain activities of medicinal products are required to receive training on GDP and how it pertains to the duties they perform. Deficiencies that may be observed during a regulatory audit include:

  • Personnel conducting duties prior to being trained on the relevant procedures, guidelines, and legislation of GDP
  • When a Responsible Person (RP) has been assigned, a role profile (job description) did not include all the required responsibilities as per Chapter 2 of the EU guidelines
  • No evidence of maintaining competence through regular training/refresher training
  • There was no company requirement for an assessment of the effectiveness of training to be conducted or it was not conducted adequately

Developing a training programme that is based around the guidelines and legislation will support safeguarding end users against potential hazards in the supply chain.


Contact us today for further information on ensuring GDP compliance. HiTech Health have a team of Qualified Persons (QPs) and Responsible Persons (RPs) available to support your product portfolio.


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EudraLex Directive 2013/C 343/01 Guidelines on Good Distribution Practice of Medicinal Products for Human Use

Health Products Regulatory Authority (HPRA) – Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances

HPRA GDP Information Day – May 2022 –

HiTech Health presented at the 3rd Global Bioprocessing, Bioanalytical, and ATMP Manufacturing Congress in Dublin, Ireland

HiTech Health presented at the 3rd Global Bioprocessing, Bioanalytical, and ATMP Manufacturing Congress in Dublin, Ireland

HiTech Health are delighted to have attended the 3rd Global Bioprocessing, Bioanalytics and ATMP Manufacturing Congress on 16th and 17th May. HiTech Health’s Quality and Compliance Lead Julie-Anne O’Neill and Manager of Cell and Gene Therapy Operations Aoife Duffy presented at this in-person event and shared experiences in navigating the quality, regulatory and manufacturing challenges of ATMPs.

On day 1, Julie-Anne talked about ATMP manufacturing and regulatory challenges from a QP’s perspective, including considerations for; materials and supplier control, manufacturing complexities, sterility assurance, release strategy and regulatory, training and personnel, traceability of ATMPs, stability; and concessionary release. ATMPs are complex products and risks may differ according to the type of product, nature or characteristics of the starting materials as well as the level of complexity of the manufacturing process. This presents a number of unique challenges to ATMP development and manufacturing that Julie-Anne talked about on the day.

It is important to have a QP experienced in ATMPs involved as early as possible in the development process to ensure quality and compliance standards are met. You can find out more about our QP services here.

On day 2, Aoife presented how to create and establish an ATMP infrastructure and what is needed to build a robust supply chain for cell and gene therapies. Aoife talked about key considerations for building the right capabilities and systems to ensure patients receive the vital therapies. During the presentation, Aoife announced that during the early stage of the Covid-19 pandemic, HiTech Health established a laboratory in County Galway, providing process and analytical development services. The company now has two R&D laboratories operating and offers a growing range of services in the ATMP space. The next expansion phase, adding GMP clean rooms, is almost completed and will include manufacturing services for clinical trial materials.

We would like to thank Global Engage for organising this exciting event as well as the attendees who engaged with this year’s Global Bioprocessing, Bioanalytics and ATMP Manufacturing Congress in Dublin.

Understanding the New EU Clinical Trial Regulation (CTR)

Understanding the New EU Clinical Trial Regulation (CTR)

On the 31st January 2022, The Clinical Trials Regulation ((Regulation (EU) No 536/2014)) became effective and replaced the previous Directive (EC) 2001/20/EC and corresponding national legislation. The Clinical Trials Regulation (CTR) coordinates the review and regulatory process for drug clinical trials across the EU. Prior to the implementation of the new CTR, clinical trial sponsors were required to submit clinical trial applications separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial.


The new CTR enables sponsors to submit a single application via an online platform known as the Clinical Trials Information System (CTIS) for approval to run a clinical trial in up to 30 EEA countries. The goal is to optimise the clinical trial process and make it more efficient to conduct pan-European trials. The regulation seeks to provide a single, unified portal and database for both trial sponsors and regulatory agencies in each member state. For sponsors, the portal will be the main platform to submit applications and notifications allowing regulators to conduct their assessments and supervise the trial. During a clinical trial, users of CTIS can collaborate with national regulators while recording the results. In addition to this, the CTIS enables the monitoring of results and assessing safety-related data in this single integrated online platform.


The CTR and CTIS aims include the implementation of clinical trial regulations, to improve the efficiency and transparency of drug clinical trials and ensure the highest safety standards for trial participants. Under the new CTR, clinical trial sponsors can use the Clinical Trials Information System (CTIS) from 31 January 2022, but are not obliged to use it immediately, in line with a three-year transition period. National regulators in the EU Member States and EEA countries will use CTIS from 31st January 2022. The Clinical Trials website can be visited here and the CTIS can be visited here where you can find out more information.


Learn more about our cell and gene therapy services by clicking here:

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Cell and Gene Therapies: 3 Key Supply Considerations

Cell and Gene Therapies: 3 Key Supply Considerations

Personalised medicines involve an increased degree of complexity when it comes to manufacturing and supply in comparison to traditional pharmaceuticals. The Horizon 2020 Advisory Group defines personalised medicine as ‘a medical model using the characterisation of individuals’ phenotypes and genotypes (e.g. molecular profiling, medical imaging, lifestyle data) for tailoring the right therapeutic strategy for the right person at the right time, and/or to determine the predisposition to disease and/or to deliver timely and targeted prevention.’ Personalised medicine focuses on treating patients based on their individual clinical characteristics, the diversity and severity of symptoms, and genetic traits. Cell and gene therapies (CGTs) are an increasingly important segment of personalised treatments. CGTs are typically expensive treatments manufactured in low volume. Due to the time-sensitive nature and challenging temperature conditions associated with manufacturing, handling and treating patients with cell and gene therapies, this article outlines some considerations for the handling and supply of CGT products.


Consideration 1: Transportation

Many CGTs are transported and stored at ultra-low temperatures including cryogenic temperatures below -80 °C. Primary materials and therapies may be required to be shipped from the site of manufacturing to the clinical setting within 40 to 50 hours typically. Maintaining the integrity of cell and gene therapy products during shipping, as well as ensuring that they arrive on time and within the appropriate temperature constraints, is a major challenge. CGT companies should consider:

  • Has the optimal courier been selected who has experience with transporting high-value, temperature-sensitive cell and gene therapies?
  • Is the selected shipping system suitable and validated for transporting the materials?
  • Has a risk assessment been performed to mitigate any delays or incidents that may arise during transportation?
  • Is the necessary documentation available to successfully export and import the CGTs across territories?
  • What processes are in place at the receiving site to ensure the CGTs arrive undamaged, viable and fit for administration?

Issues experienced during transportation can be possibly devastating for patients and highly costly for clinical trial sponsors as CGTs can cost $200,000–2,000,000 per dose. A commercially viable supply chain is recommended to be in place at the start of clinical trials (even in Phase 1) as many of these therapies are given orphan (US) and prime (EU) status which could allow them to gain approval in a shortened timeframe should the clinical trials be successful.


Consideration 2: Sourcing of Materials

Materials and equipment used in the manufacturing and supply of cell and gene therapies may be more challenging to acquire in contrast to traditional pharmaceutical products. For example, high quality specialised reagents are critical to maintaining healthy cell cultures that perform optimally and consistently. In many cases, companies may only have single-source suppliers and this may increase the risk of supply chain disruption. With CGTs requiring specialised raw materials and unique manufacturing equipment, CGT companies commonly chose to outsource manufacturing to CDMOs with experience in small volume, high value manufacturing and the ability to manage specialised packaging and labelling.

CGT companies may take into consideration:

  • Has an inventory management system been developed to ensure there are optimal levels of materials available?
  • Are there alternative suppliers of materials and equipment that may be qualified as a back-up source?
  • Have your key suppliers been qualified for use and audited?
  • Have Critical Quality Attributes (CQA) and Critical Process Parameters(CPP) been defined and agreed with suppliers?
  • Has a Business Continuity Plan (BCP) been developed and implemented?

Selecting and qualifying the optimal vendors to support your clinical and commercial needs is a crucial activity. Identifying risks to the provision of materials and implementing mitigation strategies could prevent detrimental impacts to product supply and ultimately to patients. Furthermore, effective communication with suppliers to coordinate and schedule activities is essential to avoid disruption.


Consideration 3: End-to-end Visibility

End‑to‑end traceability from manufacturing to final delivery of CGTs to patient treatment centers is an important consideration for successfully providing personalising treatments. A CGT supply chain may involve many different entities including contract development and manufacturing organisations (CDMOs), thermal shipping system suppliers, diagnostic companies, specialised couriers and distributors. Ensuring there is alignment between all entities should be a key area reviewed during the pre-clinical and clinical development phases.

A Chain of Identity (COI) linked to the unique identifier should be generated at patient enrolment. This identifier should be visible and traceable throughout a patient’s personalised treatment. For example, as part of the COI, an autologous donor’s patient number should be associated with their unique donation number (e.g. Donor identification number/DIN) and the manufacturing batch number. Chain of custody (COC) refers to the ownership/stakeholder ‘in‑custody’ of the cells or drug product, at any stage of the value chain. COC typically incorporates numerous critical parameters to ensure high quality standards and integrity of the cells at every step. COI and COC are key components to ensure traceability over the course of the personalised treatment and to safeguard patient safety. This can present more challenges that the traditional biopharmaceutical product supply model as adequate infrastructure and systems must ensure the correct CGT is available in time for the scheduled administration at the correct treatment site for the correct patient. Autologous cell therapies, for instance, must have robust controls in place to ensure patients receive the CGT from their own donor cells and not another patient’s cells. Important areas to closely examine in relation to end-to-end visibility include:

  • Have the COI and COC requirements been reviewed and defined?
  • Is there full traceability from the start to the finish of the CGT product lifecycle?
  • If using a CDMO, how will manufacturing activities be monitored and how will key updates be provided?
  • What processes are in place to ensure the correct CGT reaches the correct patient?


Advanced technologies including software systems can support the coordination of last mile deliveries with treatment centers. As the CGT industry continues to grow rapidly, so too will the development of technologies to provide end-to-end traceability.


To learn more about HiTech Health CGT services –  contact us.