EUROPEAN COMMISSION

DIRECTORATE-GENERAL FOR HEALTH

AND FOOD SAFETY

Brussels, 10 April 2020

(Revision 1 – 17 April 2020)

NOTICE TO STAKEHOLDERS

QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS

FOR HUMAN USE DURING THE COVID-19 PANDEMIC

Contents

INTRODUCTION ............................................................................................................... 2

A. LEGAL AND REGULATORY GUIDANCE ............................................................ 3

1. ISSUES RELATED TO MARKETING AUTHORISATIONS,

MARKETING AUTHORISATION PROCEDURES ................................................ 3
1.1. Can medicinal products intended for use in COVID-19 patients be
marketed in the absence of a marketing authorisation?..................................... 3
1.2. Can I postpone my renewal application? ........................................................... 3
1.3. Does the 'sunset clause' apply during a pandemic? ........................................... 4
2. MANUFACTURING, IMPORTATION OF FINISHED PRODUCTS AND
ACTIVE PHARMACEUTICAL INGREDIENTS AND GMP AND GDP
ISSUES ........................................................................................................................ 4
2.1. How can changes in the manufacturing/supply chain be implemented
swiftly to ensure continuity of supplies to the EU of crucial medicines
for treatment of COVID-19 patients? ................................................................ 4
2.2. [NEW] Which measures will be taken in respect of GMP certificates
and authorisations to manufacture/import in light of difficulties to
conduct on-site GMP inspections due to restrictions linked to COVID-
19 pandemic? ..................................................................................................... 6
2.3. [NEW] Which measures will be taken in respect of GDP certificates
and wholesale authorisations in light of difficulties to conduct on-site
inspections due to restrictions linked to COVID-10 pandemic? ....................... 8
 2.4. [NEW] Which adaptations to the work of the QP are possible
considering travelling and other restrictions arising from COVID-19
pandemic? .......................................................................................................... 8
i. Remote batch certification ................................................................... 8
ii. Remote audits of the active substance manufacturer .......................... 9
iii. Batch release of investigational medicinal products imported
from third countries ............................................................................. 9
3. QUALITY VARIATIONS .......................................................................................... 9
3.1. Can quality requirements be waived/adapted for medicines intended to
be used for the treatment of COVID-19 patients? ............................................. 9
4. PHARMACOVIGILANCE, INCL. ADVERSE REACTIONS
REPORTING............................................................................................................. 10
4.1. [NEW] Is there any impact on reporting into EudraVigilance of
Individual Case Safety Reports (ICSRs)? ....................................................... 10
5. PRODUCT INFORMATION AND LABELLING .................................................. 11
5.1. Is there any flexibility in the labelling and packaging requirements to
facilitate the movement of medicinal products within the EU? ...................... 11
B. ADDITIONAL INFORMATION ............................................................................. 12

2
 INTRODUCTION

The current COVID-19 pandemic has a considerable impact on citizens, patients and
businesses. It may force marketing authorisation holders of medicinal products and
regulatory authorities to operate under business continuity mode, impacting the
standard way of working. Moreover, public health needs may require quick actions or
re-prioritisation of operations.

The ultimate aim of the EU legislation on medicinal products is to ensure a high level
of public health. The COVID-19 pandemic is posing unprecedented challenges and
ensuring continuity of supplies of medicines is a priority for public health. Therefore,
it is necessary to articulate appropriate measures to minimise risks of shortages while
ensuring that the high standards of quality, safety and efficacy of medicines made
available to patients in the EU are maintained.

This document provides guidance to marketing authorisation holders of medicinal

products for human use (“MAH”) on regulatory expectations and flexibility during
the COVID-19 pandemic. The document will be updated to address new questions
and to adjust the content thereof to the evolution of the pandemic. For queries related
to specific products that are not specifically addressed in this document, MAHs are
invited to address the European Medicines Agency (for centrally authorised products)
or the relevant national competent authorities (for nationally authorised products).

This document remains valid until further notice. It has been developed in
cooperation between the European Commission, the Coordination group for Mutual
recognition and Decentralised procedures – human (“CMDh”), the Inspectors
Working Group and the European Medicines Agency (“EMA”).

The ultimate responsibility for the interpretation of EU legislation is vested on the

European Court of Justice and therefore the content of this document is without
prejudice to a different interpretation that may be issued by the European Court of
Justice.

A. LEGAL AND REGULATORY GUIDANCE

1. ISSUES RELATED TO MARKETING AUTHORISATIONS, MARKETING AUTHORISATION

PROCEDURES

1.1. Can medicinal products intended for use in COVID-19 patients be

marketed in the absence of a marketing authorisation?

A marketing authorisation is required before medicinal products can be marketed in

the EU. A marketing authorisation granted by the European Commission is valid in
all Member States (centralised marketing authorisation). A marketing authorisation
granted by a National Competent Authority (“NCA”) in a Member State is valid
only in that Member State (national marketing authorisation). Procedures exist to
facilitate the granting of national marketing authorisations of medicinal products
that are authorised in another EU/EEA Member State.1

1
Mutual recognition procedure (“MRP”) and decentralised procedure (“DCP”) established by Directive
2001/83/EC.
3
The coordination group established under Article 27 of Directive 2001/83/EC
(CMDh) has agreed to promote the use of zero-day mutual recognition
procedure/repeat use procedure to expand national marketing authorisations to new
Member States who need these medicinal products.

Member States may also authorise a medicinal product that has already been
authorised in another EU Member State in accordance with Article 126a of
Directive 2001/83/EC.

In cases where no centralised/relevant national marketing authorisation exists,

Member States can make use of possibilities foreseen in Directive 2001/83/EC,
including resorting to compassionate use, or authorisation of the distribution of an
unauthorised medicinal product in accordance with Article 5(2) of Directive
2001/83/EC.

To permit prompt assessment of these requests, applicants are requested to identify

any such communication to the relevant NCA with the message “CONCERNS
COVID-19”.

1.2. Can I postpone my renewal application?

According to Article 14 of Regulation (EC) No 726/2004 and Article 24 of

Directive 2001/83/EC the initial standard marketing authorisation is valid for five
years. Such marketing authorisation may be renewed on the basis of a re-evaluation
of the benefit-risk assessment. To this end, the MAH shall provide the Agency or
the NCAs with a consolidated version of the file in respect of quality, safety and
efficacy, at least 9 months before the marketing authorisation ceases to be valid.

MAHs facing difficulties to meet this deadline due to exceptional circumstances

arising from the COVID pandemic, are invited to contact the EMA (for centrally
authorised products) or the reference Member State (for products authorised under
the MRP/DCP) before the foreseen deadline of the submission of the renewal
application with a justified request to postpone the submission of the complete
dossier to a later point in time. The reference Member State will consult with the
concerned Member State(s) and advice the MAH on any further step to be taken
before the foreseen deadline. In case of purely national marketing authorisations,
the relevant national competent authority should be contacted.

The same considerations apply to conditional marketing authorisations granted in

accordance with Article 14-a of Regulation (EC) No 726/2004.

1.3. Does the 'sunset clause' apply during a pandemic?

According to Article 24(4) to (6) of Directive 2001/83/EC and Articles 14(4) to (6)
of Regulation (EC) No 726/2004, any authorisation which within three years of its
granting is not followed by the actual placing on the market of the authorised
product in the authorising Member State or on the Union market will cease to be
valid. When an authorised product previously placed on the market in the
authorising Member State or in the Union is no longer actually present on the
market for a period of three consecutive years, the authorisation for that product will
cease to be valid.

4
 Due to the current pandemic, initial market launch plans may need to be adapted in
a way that could trigger the sunset clause mechanism. MAHs are reminded of the
possibility to request an exemption in view of exceptional circumstances and on
public health grounds.

For centrally authorised products such request has to be submitted under Article
14(6) of Regulation (EC) No 726/2004 to the European Commission. During the
pandemic, the Commission may accept sunset clause requests that refer to the
pandemic as a reason without the need for any further justification.

For nationally authorised products such requests have to be submitted to the

competent authorities of the Member State(s) concerned. It will be decided
according to the national rules considering the pandemic situation.

2. MANUFACTURING, IMPORTATION OF FINISHED PRODUCTS AND ACTIVE

PHARMACEUTICAL INGREDIENTS AND GMP AND GDP ISSUES

2.1. How can changes in the manufacturing/supply chain be implemented

swiftly to ensure continuity of supplies to the EU of crucial medicines for
treatment of COVID-19 patients?

MAHs may experience supply chain/manufacturing disruptions due to

manufacturing, distribution and trade restrictions arising from the COVID-19
pandemic. Ensuring continuity of supplies of medicinal products is a priority for
public health.

It is therefore necessary to articulate regulatory tools that permit MAHs to swiftly

source starting materials, reagents, intermediates or active substances from
alternative suppliers, where that is necessary to ensure supplies to the EU of crucial
medicines for treatment of COVID-19 patients. The addition of new manufacturing
sites for part or all of the manufacturing process, as well as changes in the site(s)
responsible for quality control should also be facilitated.

To reduce the risk of shortages or disruption of supply following from

manufacturing and/or supply problems, an exceptional change management process
(ECMP) is made available to MAHs of crucial medicines for treatment of COVID-
19 patients. The ECMP will permit the swift implementation of changes to suppliers
and/or manufacturing/control sites necessary to reduce the risks of shortages under
certain conditions intended to ensure the quality of the medicinal product, while
deferring the full assessment of the variation.

Under the ECMP, MAHs will be able to exceptionally source starting materials,
reagents, intermediates or active substances from suppliers not specifically
mentioned in the marketing authorisation if that is necessary to prevent/mitigate
shortages of supplies in the EU. Likewise, MAHs will be able to use manufacturing
sites or sites responsible for quality control that are not specifically mentioned in the
marketing authorisation in cases where the use of an alternative site is necessary to
prevent/mitigate shortages of supplies in the EU.

5
 Scope

The ECMP is only available for crucial medicines for use in COVID-19 patients.2

The ECMP cannot apply to changes classified as extensions of the marketing

authorisation in accordance with Annex I of Commission Regulation (EC) No
1234/2008. In addition, it is only available for changes required to address supply
chain/manufacturing challenges resulting from the current pandemic with a view to
ensure continuity of supplies. Deviations from the requirements in the marketing
authorisation or from GMDP3 (other than aspects intrinsically linked to the changes
of suppliers and/or manufacturing/control sites) are excluded from the ECMP.

Procedure

MAHs that wish to rely on the ECMP must notify the relevant national competent
authority that granted the marketing authorisation or EMA (in case of centrally
authorised products). In the notification, the MAH should:

 Specify the intention to use the ECMP for the specific medicinal product.

 Commit to ensure that the quality of the finished product will not be
compromised. To this end, the MAH should ensure that the new
suppliers/sites abide by the quality standards applicable in the EU and, in
particular, that the specifications (both for active substance(s) and finished
product) in the marketing authorisation are respected. Where required by EU
legislation, manufacturing/control site used under the ECMP should have an
EU GMP certificate or have been certified by the authorities of a country with
whom the EU has concluded a mutual recognition agreement. 4 If the latter
conditions are not met, a variation in accordance with Commission
Regulation (EC) No 1234/2008 should be submitted.

 Commit to notify any changes to the relevant competent authorities within

48 hours after the change is implemented by the MAH. In the case of
centrally-authorised products, notifications should be made to the EMA. The
notification should indicate the medicinal product that is concerned as well a
summary description of the change made.

 Commit to submit the corresponding variation application to the competent

authorities no later than within 6 months following the implementation of the
change. Grouping of relevant variations in accordance with Commission
Regulation (EC) No 1234/2008 remains possible.5 The variation submission

2
When in doubt whether a given medicinal product is a crucial medicine for treatment of COVID-19
patients, the MAH may contact the relevant competent authorities (EMA should be contacted for
centralised marketing authorisations).
3
Good Manufacturing and Distribution Practices.
4
It is acknowledged that the GMP certificate for the site may not specifically cover the medicinal product
at stake.
5
Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of
variations to the terms of marketing authorisations for medicinal products for human use and veterinary
medicinal products.

6
 should provide all the data requirements provided for under the Guidelines on
the details of the various categories of variations, on the operation of the
procedures laid down in Chapters II, IIa, III and IV of Commission
Regulation (EC) No 1234/2008 of 24 November 2008 concerning the
examination of variations to the terms of marketing authorisations for
medicinal products for human use and veterinary medicinal products and on
the documentation to be submitted pursuant to those procedures.

The relevant competent authority will assess the notification and specifically
whether the application concerns crucial medicines for use in COVID-19 patients
(in case of marketing authorisations granted under the mutual recognition or the
decentralised procedure, the reference Member State will consult the concerned
Member States). Within two working days, the MAH will be informed whether the
relevant competent authority has agreed to the application of the ECMP. If within
two working days following the submission date the relevant competent authority
has not raised objections, the application of the ECMP shall be deemed accepted.

The agreed ECMP can cease to be valid in case one or more of the above-referred
commitments are not fulfilled (including e.g. that critical findings in respect of the
quality of the product are identified).

2.2. [NEW] Which measures will be taken in respect of GMP certificates and
authorisations to manufacture/import in light of difficulties to conduct
on-site GMP inspections due to restrictions linked to COVID-19
pandemic?

The COVID-19 pandemic has triggered national and international restrictions that
may affect and/or prevent the conduct of certain on-site GMP inspections. In light
of the severity of the current circumstances, measures should be put in place to
ensure availability of GMP certificates and authorisations to manufacture/import to
support regulatory submissions, as well as to maintain the validity of current GMP
certificates and authorisations to manufacture/import.

Specifically, the validity of GMP certificates that support the manufacture and
importation of medicinal products in the EEA should be extended to avoid
disruptions in the availability of medicines. The validity of authorisations to
manufacture/import should also be extended (in case they are time-limited). With a
view to ensure the quality of medicines marketed in the EU/EEA, a distinct
approach should be taken for sites that are located in the EEA and sites located
outside the EEA that have never been inspected by an EEA supervisory authority.

Sites located in the EEA

The validity of GMP certificates for manufacturing/importing sites of active

substances and/or finished products in the EEA should be extended until the end of
2021without the need for further action from the holder of the certificate. 6 This
automatic extension does not cover changes in the scope of the GMP certificate (e.g.
new buildings, new medicinal products).

6
An explanatory footer has also been introduced in EudraGMDP database.

7
 The validity of time-limited authorisations/registrations to manufacture/import
should also be extended until the end of 2021 without the need for further action
from the authorisation/registration holder. This automatic extension does not cover
changes in the scope of the authorisation/registration (e.g. new premises, new
medicinal products).

For new sites/facilities in the EEA that have never been inspected and authorised, a
distant assessment may be conducted in order to evaluate if the site could be
authorised without a pre-approval inspection. In such cases, it should be indicated
that the certificate has been granted on the basis of a distant assessment. Moreover,
an on-site inspection should be conducted when circumstances permit. If the
outcome of the distant assessment does not permit the granting of the GMP
certificate, a clock-stop will be triggered until an on-site inspection is possible.

Sites located outside the EEA

The validity of GMP certificates for manufacturing sites of active substances and/or
finished products located outside the EEA should be extended until the end of 2021
without the need for further action from the holder of the certificate, unless the
issuing/supervisory authority takes any action that affects the validity of the
certificate.

For new sites/facilities in third countries where an inspection is required, and where
there is no operational mutual recognition agreement (MRA) or the scope is not
covered by the MRA, a distant assessment by an EEA supervisory authority may be
conducted. A GMP certificate may be granted depending on the outcome of the
assessment. In such cases, it should be indicated that the certificate has been
granted on the basis of a distant assessment. Moreover, an on-site inspection should
be conducted when circumstances permit. If the outcome of the distant assessment
does not permit the granting of the GMP certificate, a clock-stop will be triggered
until an on-site inspection is possible.

Important remarks

Pre-approval or routine on-site inspections will resume as soon as COVID-19

restrictions are lifted,7 according to risk based inspection planning taking into
account the date of the last inspection.

It is stressed that the obligation of manufacturers and importers to comply with

GMP is not waived. It is incumbent upon manufacturers and importers to continue
complying with GMP. Supervisory authorities will remain vigilant to ensure the
quality of medicines that are made available to patients in the EEA. Inspections
(including distant assessments) may be launched at any time and, in case of non-
compliance, appropriate regulatory actions will be triggered.

7
Resumption of inspections will vary according to timing of the lifting of containment measures taken by
each country and other factors such as restoration of transport links.

8
 2.3. [NEW] Which measures will be taken in respect of GDP certificates and
wholesale authorisations in light of difficulties to conduct on-site
inspections due to restrictions linked to COVID-10 pandemic?

In light of difficulties to conduct on-site GDP inspections due to restrictions arising

from the COVID-19 pandemic, the validity of GDP certificates should be extended
until the end of 2021 without the need for further action from the holder of the
certificate.

The validity of time-limited wholesale authorisations should also be extended until

the end of 2021 without the need for further action from the holder of the
authorisation.8 This automatic extension does not cover changes in the scope of the
authorisation (e.g. type of medicinal products or authorised operations).

On-site inspections will resume as soon as COVID-19 restrictions are lifted,9

according to risk based inspection planning taking into account the date of the last
inspection.

It is stressed that the obligation of distributors and wholesalers to comply with GDP
is not waived. It is incumbent upon distributors and wholesalers to continue
complying with GDP. Supervisory authorities will remain vigilant to ensure the
quality of medicines that are made available to patients in the EEA. Inspections
(including distant assessments) may be launched at any time and, in case of non-
compliance, appropriate regulatory actions will be triggered.

2.4. [NEW] Which adaptations to the work of the QP are possible considering
travelling and other restrictions arising from COVID-19 pandemic?

i. Remote batch certification

The remote batch certification is permissible under EU GMP rules, provided that the
QP has access to all information necessary to enable them to certify the batch.

While in some Member States additional requirements have been introduced which
may preclude remote certification, considering the current restrictions of travelling
linked to the COVID-19 pandemic, the remote certification should be acceptable in
all EEA Member States.

It is stressed that the obligations/responsibilities of the QP remain unchanged.

ii. Remote audits of the active substance manufacturer

Where on-site audits are not possible, the QP can rely on paper-based audits and
also take into consideration the results of inspections from EEA authorities.10

8
An explanatory footer has also been introduced in EudraGMDP database.
9
Resumption of inspections will vary according to timing of the lifting of containment measures taken by
each country and other factors such as restoration of transport links.
10
Guidance on good manufacturing practice and good distribution practice: Questions and answers.
https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-
practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers#eu-gmp-
9
 Remote audits should provide confidence that the active substance is fit-for-purpose
and will not negatively affect the safety and efficacy of the medicinal product. The
QP is expected to justify the controls in place on a scientific basis and record a risk
assessment on a product specific basis.11

iii. Batch release of investigational medicinal products imported from third

countries
In case of imports of investigational medicinal products from third countries, the QP
should ensure that the quality of the batch is in accordance with the terms of the
clinical trial authorisation (including compliance with the terms of the Product
Specification File) and that it has been manufactured in accordance with quality
standards at least equivalent to the GMP requirements applied in the EEA.

To make that assessment, where on-site inspections are not possible, the QP may
rely on a variety of documents including, as appropriate: batch records, including in-
process test reports and release reports, the validation status of facilities, processes
and methods, examination of finished packs, the results of any analyses or tests
performed after importation (where relevant), stability reports, the source and
verification of conditions of storage and shipment, audit reports concerning the
quality system of the manufacturer, etc.

3. QUALITY VARIATIONS

3.1. Can quality requirements be waived/adapted for medicines intended to

be used for the treatment of COVID-19 patients?

Without prejudice to the flexibilities afforded by the ECMP, the quality

requirements foreseen in the marketing authorisation should be complied with for
medicinal products marketed in the EU, including medicinal products that are
administered to COVID-19 patients.

MAHs facing difficulties to perform the quality controls foreseen in the marketing
authorisation, due to e.g. a significant increase of manufacturing capacity to meet
the demands of patients in the EU or other circumstances related to the COVID-19
pandemic, are invited to contact the competent authorities and to present an adapted
control scheme based on a risk-based approach. This request should be submitted as
a variation in accordance with Commission Regulation (EC) No 1234/2008.

Other changes to the quality requirements foreseen in the marketing authorisations

should also be processed in accordance with the Commission Regulation (EC)
No 1234/2008.

To permit prompt assessment of these variation applications, applicants are

requested to identify any such communication with the subject “CONCERNS
COVID-19” next to the procedure number in the email heading.

guide-part-ii:-basic-requirements-for-active-substances-used-as-starting-materials:-gmp-compliance-for-
active-substances-section
11
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-template-qualified-
persons-declaration-concerning-good-manufacturing-practice-gmp_en.pdf

10
4. PHARMACOVIGILANCE, INCL. ADVERSE REACTIONS REPORTING

4.1. [NEW] Is there any impact on reporting into EudraVigilance of

Individual Case Safety Reports (ICSRs)?

According to Article 107 of Directive 2001/83/EC, MAHs shall submit

electronically to the Eudravigilance database all serious suspected adverse reactions
that occur in the Union and in third countries within 15 days following the day on
which the MAH gained knowledge of the event. All non-serious suspected adverse
reactions that occur in the Union shall be submitted within 90 days.

This includes adverse reactions that result from use outside the terms of the
marketing authorisation (off-label use).

During the current pandemic the reporting of adverse events related to the
widespread use of medicinal products for the treatment or prevention of the
pathogen causing the pandemic may increase. At the same time, there is a risk that
during a pandemic workforces in industry may be reduced due to high employee
absenteeism.

These exceptional circumstances may force companies to activate business

continuity plans and prioritise activities. Therefore, in case MAHs are for justified
reasons relating to the pandemic unable to continue standard reporting operations,
they should temporarily – until the pandemic is resolved – prioritise the reporting
obligations as follows:

 Submission of serious ICSRs associated with medicinal products used for

the treatment or prevention of the pathogen causing the pandemic;

 Submission of other serious ICSRs;

 Submission of non-serious ICSRs associated with medicinal products used

for the treatment or prevention of the pathogen causing the pandemic;

 Submission of other non-serious ICSRs.

While in the present exceptional circumstances, some MAHs may have

understandable difficulties complying with the relevant deadlines, it is essential that
MAHs report all serious ICSRs within the 15 days set out in Directive 2001/83/EC.
Where MAHs make use of prioritisation, they shall put a note in the
pharmacovigilance system master file recording such practice.

For reports originating from compassionate use or named patient use, marketing
authorisation holders should continue to follow the guidance in GVP Module VI
Section VI.C.1.2.2.

5. PRODUCT INFORMATION AND LABELLING

5.1. Is there any flexibility in the labelling and packaging requirements to

facilitate the movement of medicinal products within the EU?

It is necessary to facilitate the movement of medicinal products within the EU so

that they can be made available in the Member States where are needed the most. In
11
 the current exceptional circumstances, the regulatory flexibilities foreseen in the
Directive 2001/83/EC should be fully utilised. Under Article 63(3) of Directive
2001/83/EC Member States may grant full or partial exemptions to certain labelling
and packaging requirements to address severe problems in respect of the availability
of medicinal products.

During the COVID-19 pandemic, Member States may therefore accept that the
product information of products marketed in their territory may not be translated
into the relevant official language if there are severe problems of availability of that
medicinal product in the Member State.

In these exceptional circumstances, it may moreover be accepted that national

specific information does not appear in the packaging/labelling, or that the
presentation differs from the presentations authorised in the Member State where
the product is marketed.

During the COVID-19 pandemic, the CMDh has agreed to apply the labelling and
packaging flexibilities above-referred crucial medicines for use in COVID-19
patients.12

MAHs are required to notify the relevant national competent authorities in advance
and should also provide a link to a website where the product information in the
relevant official language may be obtained. Further guidance on specific national
requirements/procedures will be developed by CMDh.

B. ADDITIONAL INFORMATION

The websites of the Commission (https://ec.europa.eu/health/human-use_en) and of the

EMA (https://www.ema.europa.eu/en/human-regulatory/overview/public-health-
threats/coronavirus-disease-covid-19) provide additional information. For products
authorised in decentralised or mutual recognition procedures, additional information will
be provided through the websites of the Coordination Group. These pages will be
updated with further information, where necessary.

European Commission Heads of Medicines Agencies European Medicines Agency

Directorate-General Health and Food
Safety

12
When in doubt whether a given medicinal product is a crucial medicine for treatment of COVID-19
patients, the MAH may contact the relevant competent authorities (EMA should be contacted for
centralised marketing authorisations).

12