NCAs Archives - European Industrial Pharmacists Group (EIPG)

ACT EU’s Workplan 2022-2026


by Giuliana Miglierini The implementation phase of the Accelerating Clinical Trials in the EU (ACT EU) initiative, launched in January 2022 by the European Commission, started with the publication of the2022-2026 Workplan jointly drafted by the Commission, the European Medicines Read more

EFPIA’s Annual Report on the Pharmaceutical industry 2022


by Giuliana Miglierini “In the 21 years from 2000 to 2021 – in which time we’ve come through the Global Financial Crisis and a pandemic – EFPIA companies have more than doubled production, increased exports by a factor of six, Read more

Webinar: Contamination Control Strategy, an Implementation Roadmap


The next EIPG webinar will be held in conjunction with PIER and University College Cork on Friday 23rd September 2022 (16.00 CEST), on the implementation roadmap of Contamination Control Strategy (CCS). This presentation is given by Walid El Azab, Read more

EMA’s Q&A on the integration of EudraGMDP and OMS

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by Giuliana Miglierini

A new step in the integration at the central level of data needed to manage regulatory procedures is going to be activated on 28 January 2022: starting from this date, member states’ national competent authorities (NCAs) shall use the data available in EMA’s Organisation Management System (OMS) to issue all type of certificates regulated under the EudraGMDP database, for human, veterinary and experimental medicines, as well as active substances (API).

A Questions & Answers guideline on the integration of EUdraGMDP and OMS has been released by EMA; the document reflects the points of discussion which arose in the course of a webinar organised by EMA to better inform about the new modalities for the release of the certificates and other services provided through the OMS system, and how to face the change request process.

The new procedures to uniquely identify the interested parties

As discussed few weeks ago on this blog, the use of the OMS dictionary became mandatory for all centrally authorised products (CAPs) since 1st November 2021. The integration of OMS with EudraGMDP database is a specific requirement arising from the new Veterinary Medicinal Products Regulation ((EU) 2019/6), which will become fully applicable on 28 January 2022.

The new procedures refer to different types of certificates, including the Manufacturing and Importation Authorisations (MIA), the Wholesale Distributor Authorisations (WDA), GMP and GDP certificates and API Registration certificates. GDP certificates will maintain their current validity, with re-inspections to occur after 5 years at the latest. Any new GMP certificate/authorisation for Clinical trials issued after 28 January 2022 will be also impacted. CEP certificates of suitability issued by the EDQM fall out of the scope of EudraGMDP, and are thus not impacted.

Should there be two different organisations with the same legal address, each of them will have a distinct ORG ID in the system; a single organisation with two different locations will have two LOC IDs. Multiples ORG IDs will be generated for marketing authorisation holders (MAHs) located in one country and having subsidiaries in other countries, as the identification is specific to the single subsidiary/location. A particular case may be represented by India, where some plots are recognised as one address by National postal services. In that case, just one LOC ID will be available; on the contrary, should the plot be not recognised as a single address, different LOC IDs will be generated.

In case of a single warehouse for human and veterinary medicines for a single company with a single address, the OMS will only have 1 contact; in these instances, NCAs will select if the certificate applies to human or veterinary medicinal products.

In the case of transfer of the location under another organisation, the OMS system is provided with the technical functionality to move the location from an organisation to another. Nevertheless, advices EMA, the activation of this procedure requires a careful verification and validation of the supporting documentation in order to avoid breaking the business rules of both EudraGMDP and OMS.

Changes requests and Super users

Since the end of January, NCAs shall extract from the OMS database all data relative to the specific organisation (i.e. name and location address details, including the legally registered address).

It is thus of paramount importance that all interested parties which appear on documents recorded in EudraGMDP – i.e. pharmaceutical companies, contract manufacturing organisations (CMOs), importers and distributors, both EU and non-EU – shall verify the correctness of their data registered in the database prior to the submission of any new or updated application for manufacturing or wholesale distribution authorisation with national competent authorities.

Should the submission of a change request be needed, anyone among the interested parties may provide to file it with EMA. Change requests can be submitted starting from 28 January 2022; the requests have to be validated by EMA against the reference sources (e.g. Trade registry and Postal services) before the OMS Data stewards can proceed to change the data in the system.

The availability of the correct information is particularly important in the case of CMOs located in extra-EEA countries, and which may request inspections or need to update their GMP certificates. EMA’s advices companies to promptly liaise with their partners to manage in due time any change request needed to correct data recorded in the OMS.

The “Organisation Super users” can verify all of the users affiliated to their respective organization through the EMA’s Account management portal; they can also change the user roles and users affiliated at any point in time. EMA suggests companies to have at least two Super users, in order to guarantee one of them is always available and active. A single Super user can be affiliated with different organisations.

Other answers provided by the guideline

The Q&As guideline published by EMA consists of 87 questions and their corresponding answers. Question n°2 addresses the issue of the legal basis of GDP certificates for Veterinary medicines: as the new Regulation and its associated secondary legislative acts still do not include such a legal basis, EMA will update the GDP module of EudraGMDP after January 2022 in order to provide consistency in the approach. It shall thus be possible for NCAs to voluntary use the database to record GDP certificates for companies distributing veterinary medicines. The guideline also indicates that national competent authorities are prepared to the handle the new framework and can plan in advance activities needed in the near time to issue WDA and API Registration certificates for veterinary Organisation.

Even if the use of OMS is yet mandatory for CAPs only, the Q&As guideline indicates that NCAs need to ensure that the relevant organisations are available in OMS before submitting information into the system, both for CAPs and non-CAPs. The suggestion is thus to ensure that the OMS data is present and correct for all organisations/sites, even if its use in electronic application forms (eAF) is not mandatory for the time being.

Details of manufacturing sites such as buildings or plots are not registered in OMS, but they have to be included in the GMP certificate; this extra information will be inserted in the ‘Restrictions’ section of the certificate. There is no change to the procedures for the issuing of GMP certificates.

When a change to an organisation occur in the OMS, the dictionary part of EudraGMDP gets refreshed, but no change is reflected in the documents already issued unless there is a specific action on them. The synchronisation between the two databases occurs on the following business day after the change was registered.

In case of transfer of the company to a new location, the change has to be registered in the OMS before new certificates can be issued; according to the guideline, this should not represent a problem while the current certificate are still valid.

During the webinar some doubts have been expressed as for the possible confusion arising from the guidance document “Manufacturer organisations in the OMS dictionary” (EMA/465039/2018), which divides OMS data responsibility for manufacturers and MAHs/Applicants. This document shall be reviewed by the Agency, says EMA’s guideline.


A study on medicines shortages from the European Commission

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by Giuliana Miglierini

The study on medicines shortages commissioned in March 2020 by the European Commission upon request of the European Parliament and Council has been published; the document, prepared by a consortium led by Technopolis, suggests 16 possible policy measures – both legislative and not-legislative – that the Commission may consider while drafting a new legislative proposal to govern the issue, expected to be announced at the end of 2022.

According to the current EU pharmaceutical legislation (Directive 2001/83/EC), marketing authorization holders (MAHs) have to submit – two months before the temporary or permanent interruption of supply of a certain medicinal product – a pre-notification to the relevant national competent authorities (NCAs) (Article 23a, a part in the case of exceptional circumstances).

The mandate to continue supply to cover the needs of patients, and respective responsibilities of MAHs and wholesale distributors are established by Article 81 of the same directive.

The new study will support some of the achievements set forth in the Pharmaceutical Strategy; another action undertaken to reduce the impact of shortages in the EU is represented by the EU Executive Steering Group on Shortages of Medicines Caused by Major Events, an initiative set up in March 2020 with the contribution of the Commission, EMA and member states.

The Commission study on shortages by Technopolis confirms that current market framework conditions for off-patent medicines play against supply resilience – said Rebecca Guntern, President ad-interim of Medicines for Europe, commenting the release of the study –. As long as healthcare systems only focus on the cheapest possible price for off-patent medicines and do not reward investments to ensure robust supply chains, the only option for companies is to be the cheapest or to leave the market.

The main outcomes of the study

The study on shortages focused its attention on medicines for human use marketed in the EU/ EEA in the period 2004-2020. The main objectives of the exercise include the identification of shortages’ root causes and specific characteristics, the assessment of the adequacy of the current framework (at EU and national level) and of possible solutions to address the problem.

Data from the shortages registries kept by national competent authorities (NCAs) of 22 EU’s countries was only available for years 2007-2020. Commercial data on pharmaceutical sales from IQVIA MIDAS was also used, and extensive consultation with stakeholders was run under different formats.

Central to the 16 recommendations highlighted in the study is the establishment of a centralized and harmonised EU-wide definition of medicine shortages, as well as of harmonised reporting criteria. The latter should aim to collect sufficiently detailed information on key parameters (e.g. product details, MAH, details on the shortage and impact).

Different definitions, systems for notifications and type of information requested are currently in use in the various member states; even the definition of “shortage” agreed in 2019 by EMA and HMA was not considered by stakeholders adequate to differentiate between critical and non-critical shortages. According to the report, this fragmented situation doesn’t allow for the sharing of data and comparative analysis between countries, thus resulting in the overall inefficiency of the system.

Attention should be paid also to the creation of a EU-wide list of medicines subject to critical shortages; specific policies and regulations may be developed on this basis to improve their availability. Medicines typically experiencing shortages are older, off-patent and generics drugs with low profit margins; the main therapeutic areas involved include pain, hypertension, infections and oncology.

The creation of dialogue platforms at the national level is also envisaged, where to exchange the point of view of different supply chain stakeholders (including patients and healthcare providers). The study highlights the high burden shortages create on pharmacists and physicians looking for the best possible treatment alternative for their patients. A possible way to address this issue would see the availability of information about alternative medicines in shortage databases. In many cases, this type of occurrence is referred just to some countries within the EU, thus suggesting inequitable distribution and access rather than global supply issues may play a major role in shortages.

Understanding the root causes

Limited reporting is a key point to be solved in order to improve the understanding of root causes of shortages. According to the study, a reductionist approach to reporting is often used; this makes fully evident just acute causes (e.g. a problem at the production site), but leaves unattended more systemic issues (e.g. consolidation of manufacturing, resulting in a very limited number of production sites) and market-related factors (e.g. single-winner procurement practices).

Quality and manufacturing issues account for approx. half of all cases of shortages, suggest the report; among commercial reasons are market withdrawals and unexpected increases in demand. The information available for the analysis was judged insufficient to exactly asses the potential risks linked to outsourcing of manufacturing activities (including the production of APIs) and parallel distribution.

The proposed recommendations ask for greater transparency of industry supply quotas as well as parallel traders’ and wholesalers’ transactions. Suppliers should establish adequate shortage prevention and mitigation plans; legal obligations for MAHs and wholesalers are suggested in order to maintain a safety stock of (unfinished) products for medicines of major therapeutic interest at EU-level.

A new legislation to tackle shortages

The provisions set forth by Articles 23a and 81 of the Directive have been transposed differently into the single national legislations, often well before the establishment of the shortages registries. Several EU’s countries have acted on their own to strengthen the system, for example establishing mandatory reporting on stock levels and export restrictions. Nevertheless, according to the study available data are not sufficient to draw final conclusions on the costs and efficacy of stock keeping obligations on the level of (notified) shortages in the countries where they were introduced.

A more pro-active approach to the management of medicines shortages by MAHs and distributors may be supported by the availability of a EU-wide and uniform legislation governing financial sanctions to be applied if notification requirements and/or supply responsibilities are not met. Other suggestions include the adoption of common principles for the introduction of national restrictions on intra-EU trade, and the availability of greater flexibilities for emergency imports of specific products in case of market withdrawals and other critical shortages. As for procurement, the study indicates the opportunity to address public procurement tenders also considering the incorporation of requirements for more diversified, multiple tenderers and thereby supply sources.

From a regulatory perspective, the document highlights the opportunity to reduce costs and simplify administrative procedures for the submission of post-approval changes. The availability of an accelerated mutual recognition procedure (MRP) within the EU is also suggested, together with a more efficient use of the Repeat Use Procedure. Improved flexibility should be a target also with respect to the EU-wide regulation governing medicines packaging and labelling, so to allow for the use of digital leaflets and multi-country/multi-language packaging and labelling.