CMDh_276_2012_Rev2_2013_06_-_clean.pdf

CMDh QUESTIONS & ANSWERS 

TRANSITIONAL ARRANGEMENTS FOR PSURs FOR 

NATIONALLY AUTHORISED PRODUCTS 

Doc. Ref.: CMDh/276/2012, Rev2 

June 2013 

1 REQUIREMENTS FOR PSUR REPORTING ............................................................................... 2 

2 DATA LOCK POINTS/ HARMONISED BIRTH DATES/ EURD ............................................... 4 

3 NATIONAL PSUR PROCEDURES .............................................................................................. 6 

4 FORMAT OF SUBMISSIONS ....................................................................................................... 7 

5 CORE SAFETY PROFILES ........................................................................................................... 7 

6 IMPLEMENTATION OF OUTCOMES ........................................................................................ 8 

CMDh Q&As CMDh/276/2012, Rev2, June 2013 Page 1/8 

PSURs

Nationally Authorised Product (NAP) is intended to encompass medicines authorised through Mutual 

Recognition and Decentralised Procedures and purely nationally authorised products where authorised 

in more than one Member State. The following questions and answers cover transition arrangements 

for PSURs following implementation of new pharmacovigilance legislation 21 st July 2012 and the 

introduction of the single PSUR assessment for NAPs. This document should be read in conjunction 

with the Questions and answers on practical transitional measures for the implementation of the 

pharmacovigilance legislation, published by EMA. 

http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012 

/05/WC500127658.pdf 

1 REQUIREMENTS FOR PSUR REPORTING 

1.1 For which products will routine PSUR reporting not be required? 

Unless there is a specific condition in the authorisation or it is indicated otherwise in 

the EURD for the substance concerned, routine PSUR reporting will not be required 

for medicinal products authorised under the following articles of Directive 

2001/83/EC: 

• Article 10.1 generic 

• Article 10.a well established use 

• Article 14 homeopathic medicine 

• Article 16a traditional herbal medicine 

1.2 For which types of products will routine PSUR reporting be required? 

Reporting will be required for medicinal products authorised under the following 

articles of Directive 2001/83: 

• Article 8(3) full dossier 

• Article 10.3 hybrid application 

• Article 10.4 biosimilar 

• Article 10b fixed combination 

• Article 10c informed consent 

• Any other product where there is a specific condition for PSUR reporting in the 

authorisation. 

• Where it is indicated in the EURD that, for the substance concerned, for products 

normally covered by the derogation, reporting is required. 

• In addition a PSUR shall be submitted upon the request of a Competent Authority. 

1.3 We are unclear whether routine PSUR reporting will still be required for our 

product authorised under MRP/DCP how can be confirm this? 

The legal basis under which the product was authorised in the Reference Member 

State is key to deciding whether the product is covered by the derogation. For example 

if the product was approved under Article 10.1 in the RMS and there is no indication 

in the EURD that reporting is required for generic products, then reporting will not be 

required. 


PSURs

1.4 Our product was authorised under older legislation, Article 4.8 of Directive 

65/65; will we be required to submit PSURs? 

For products authorised under Article 4.8a(ii) (well established use) or Article 4.8a(iii) 

(1 st paragraph) (essential similarity) under Directive 65/65 and Articles 10.1 a(ii) and 10 a 

(iii) of Directive 2001/83/EC (before re-codification) reporting will not be required unless 

there is a specific condition in the authorisation or there is an indication in the EURD 

that PSUR reporting is required. PSUR reporting would be required for products 

authorised under Articles 4.8 (full) , 4.8 a (i) (informed consent) and 4.8 a (iii) (2 nd 

paragraph) (hybrid application)/ 10.1/10/1 a(i). 

1.5 Our product was authorised some years ago and can be considered to be well 

established; can we stop PSUR reporting? 

PSUR reporting can only be stopped if the product was authorised under a legal basis 

covered by the derogation given in the legislation. 

1.6 When can we stop reporting for nationally authorised generics/well established 

use/homeopathics/herbals covered by the derogation? 

PSURs due for submission on or after 21 st July 2012, i.e. those with a data lock point 

on or after 21 st May 2012, do not need to be submitted if they are covered by the 

derogation, unless there is a specific condition in the authorisation or if it is indicated 

otherwise in the EURD for the substance concerned. 

1.7 We hold a MA for a product containing a substance listed on the ‘List of 

nationally approved substances for which periodic safety update reports are required 

for generic medicinal products during the transitional period’, what are the 

implications for us? 

Please refer to the cover note on this topic: 

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilanc 

e_Legislation/CMDh-282-2012-Rev0.pdf 

The Member States have reviewed the substances that have a harmonised data lock 

point between the date of implementation of the legislation (July 2012) and the date 

that the EURD became legally binding (April 2013) and have compiled a list of 

nationally authorised substances for which PSURs are required for generic medicinal 

products during this period. The NCAs consider that during the transitional period up 

to 1 st April 2013, PSURs for generics are required for those substances listed on 

pharmacovigilance grounds. 


PSURs

2 DATA LOCK POINTS/ HARMONISED BIRTH DATES/ EURD 

2.1 The EURD became binding 1 st April 2013 however some substances have been 

removed from the EURD. Which DLPs and Frequencies should be followed for 

these substances? 

Substances that are included in the EURD must follow the EU single assessment 

procedure for PSURs. This procedure has not yet been fully implemented for 

nationally authorised products and therefore substances that are not centrally 

authorised and have DLPs in 2013/2014 have been removed from the EURD for the 

time being but have been included in an extended PSUR work sharing list entitled 

“List of substances under PSUR Work Sharing scheme and other substances contained 

in Nationally Authorised Products with DLP synchronised” due to the fact that they 

will not be subject to an EU single assessment of PSURs until further notice. 

For more details, please refer to the CMDh webpage dedicated to the PSUR Work 

sharing, particularly in the document “Assessment of Periodic Safety Update Reports 

for National Authorised Products in 2013/2014 - Cover note”: 

http://www.hma.eu/348.html . 

For products containing an active substance or combination of active substances 

temporally removed from the EURD list which include an explicit condition providing 

for a specific frequency or PSUR submission date, PSURs shall be submitted in 

accordance with this particular condition instead of following the DLPs given in the 

EURD list. 

2.2 Do we have to submit variations to align our products with the PSUR data lock 

points and frequencies listed in the EURD list? 

For advice on Centrally Authorised Products please refer to the EMA Q&As on 

Practical Transitional Measures for the Implementation of the Pharmacovigilance 

Legislation. 

http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural 

_guideline/2012/05/WC500127658.pdf 

For nationally authorised products granted before 21 st July 2012, that did not have a 

legal obligation in the authorisation for PSUR frequency of submission, the EURD 

will become mandatory six months after publication and a variation will not be 

required to align with the EURD. 

2.3 Why is the PSUR frequency included in the EURD list different to the period 

covering the last DLP of my product and the DLP currently in the EURD list? 

(Example: According to the EURD list, the DLP of the substance included in my 

product is 2018 and the submission frequency 6 years. However, the last PSUR 

was submitted in 2010. Will we need to submit a 2 year report in addition to the 6 

year report?) 

The PSUR submission frequency and DLP included in the list aim at harmonising the 

submission of PSURs for products containing the same active substances. Products 

may currently have different DLPs and therefore the period between the last PSUR 


PSURs

submitted and the 1st PSUR submitted according to the EURD list may be different 

to the frequency given in the EURD. This frequency as stated in the list will 

therefore be applied, if still relevant, by all MAHs concerned as of the 2nd PSUR. 

2.4 In the EURD list DLPs are fixed on a certain date of the month in contrast to 

the Work-sharing list. Can I submit my PSUR according to any day in the 

month of the DLP published in the EURD list? 

Unlike the PSUR Work-sharing list, the DLPs in the EURD list are fixed on a certain 

date and are legally binding, therefore they should be followed. 

This enables the synchronisation of submission of PSURs for products subject to 

different MAs and facilitates the single assessment of PSURs. 

2.5 My substance appears in both the EURD list and the “List of substances under 

PSUR Work Sharing scheme and other substances contained in Nationally 

Authorised Products with DLP synchronised”. According to which list should I 

submit my PSUR? 

On 1st of April 2013, the EURD list became legally binding. This means that PSURs 

of products containing the substances and combinations of substances included in the 

list shall be submitted in line with the PSUR frequency and Data Lock Point (DLP) 

specified in the EURD list. These PSURs will be subject to an EU single assessment 

performed by the Pharmacovigilance and Risk Assessment Committee (PRAC). 

The 6 months period between the publication of the EURD list (1st October 2012) and 

the date when it became binding, (1st April 2013, see Article 107c(7) of Directive 

2010/84/EU), has been considered as a “transitional period” where PSURs shall be 

submitted in line with the periodicity and DLP agreed during this period of time for 

each product. Therefore, any DLP given in the “List of substances under PSUR Work 

Sharing scheme and other substances contained in Nationally Authorised Products 

with DLP synchronised” that are preceding the DLPs given in the EURD list (i.e. 

falling before the 1st April 2013), should be followed by MAHs of the products 

concerned for the submission of their PSURs. Such DLP may have been established in 

the frame of the PSUR work Sharing and Synchronisation project. 

The next PSURs should therefore be submitted according to the DLP as stated in the 

“List of substances under PSUR Work Sharing scheme and other substances contained 

in Nationally Authorised Products with DLP synchronized”, as at this date, the EURD 

list had not yet taken effect. These PSURs will be assessed at a national level. The 

subsequent PSURs will have to be submitted based on the EURD list. 

2.6 When a PSUR cycle has been changed is it sufficient to rely on the EURD list or 

do we have to notify the NCAs to inform them that the PSUR, which was due on 

a specific date, will be submitted in line with the EURD list instead? 

You can rely on the EURD list and there is no need to notify the NCAs. 


PSURs

3 NATIONAL PSUR PROCEDURES 

3.1 What procedures should be followed for PSUR submissions from 21 st July 2012? 

For active substances and combinations of active substances contained in centrally 

authorised medicines and in both centrally and nationally authorised medicines subject 

to different marketing authorisations and authorised in more than one Member State 

for which data lock points and frequency of submission of PSURs have been 

harmonised (EURD List) the EU single assessment procedures procedure involving 

the PRAC will apply. 

For active substances contained only in nationally authorised medicines subject to 

different marketing authorisations and authorised in more than one Member State the 

current procedures will apply i.e. either mutual recognition or national procedure until 

the EU single assessment procedure is implemented. 

Such active substances and combinations of active substances originally included in 

the EURD list with a DLP in 2013 until 31 August 2014 have been removed from the 

EURD list and transferred to the new list: “List of substances under PSUR Work 


with DLP synchronised. 

For products containing an active substance or combination of active substances 

included in the PSUR work sharing scheme, the current PSUR WS procedures without 

PRAC involvement will apply. Until the EU single assessment procedure for these 

products is implemented MAHs should continue to submit PSURs following the work 

sharing scheme 

For purely nationally authorised medicinal products authorised in only one Member 

State, the assessment of the PSUR will remain at an individual national level. 

3.2 Is PSUR work sharing compulsory? 

Participation in PSUR work sharing continues on an informal basis. The MAHs are 

encouraged to participate where PSUR submissions are required. 

3.3 Can further substances, currently on the list of synchronised birth dates be 

included in work sharing? 

If PSUR reporting is required for the product authorised to you please contact the 

EMA ( P-PV-Helpdesk@ema.europa.eu ) regarding inclusion of the substance/product 

in the work sharing project. A Reference Member State will need to be assigned for 

the PSUR assessment (P-RMS) and it would be very helpful if MAHs could 

informally agree with an NCA beforehand whether they would be willing to take on 

the responsibilities of the P-RMS. 


PSURs

3.4 In the Good Vigilance Practice Module VII it is stated that PSURs should be 

submitted within 70 calendar days of the DLP for PSURs covering intervals up to 

12 months and within 90 calendar days of the DLP for PSURs covering intervals 

in excess of 12 months; will this apply to nationally authorised products? 

Yes, the 70 and 90 day periods between data lock and submission will apply for all 

PSUR procedures. 

3.5 If an NCA is requesting a PSUR for a product where the generic products do not 

need submit a PSUR according to the List of substances under PSUR Work 


with DLP synchronized, does the MAH have to submit the PSUR to all NCAs 

where the product is authorized or only to the NCA who are requesting the 

PSUR? 

If only one NCA is requesting a PSUR the MAH should only submit the PSUR to the 

requesting NCA. If more than one NCA is requesting a PSUR the MAH should submit 

the PSUR to all MS where the product is authorized. 

4 FORMAT OF SUBMISSIONS 

4.1 Which dossier format should be used for PSURs from July 2012? 

The objective of the PSUR is to present a comprehensive and critical analysis of the 

risk-benefit balance of the product taking into account new or emerging safety 

information in the context of cumulative information on risks and benefits. Therefore 

the format has been revised and the new format is given in GVP Module VII.B.5. 

Commission Implementing Regulation (EU) No 520/2012 allowed a six month 

transition period up to 10 th January 2013 for introduction of the new format. 

PSURs submitted after 10 th January 2013 must be in the new format given in the GVP 

module. 

5 CORE SAFETY PROFILES 

5.1 Under previous arrangements for work sharing where the PSURS were 

submitted in Volume 9A format, the innovator company was required to include 

a proposal for a Core Safety Profile (CSP) in the PSUR dossier; will this still be 

required? 

During the transition period up to 10 th January 2013 a proposal for a CSP was required 

for PSURs submitted with ‘old’ format (Volume 9A) PSURs in the work sharing 

scheme. Since 10 th January PSURs are required to be submitted according to the new 

content and format and CSPs will not be required. Reference should be made to GVP 

Module VII.B.4 regarding reference documentation. 


PSURs

5.2 Will a final CSP be available at the end of the procedure? 

A CSP may be finalised for PSURs submitted in ‘old’ (Volume 9A) format during the 

transition period up to 10 th January 2013. CSPs will not be published for PSURs 

submitted and assessed under the new benefit-risk format. However, the conclusions 

of the assessment will be published. 

5.3 Will existing CSPs be updated? 

CSPs are only required for PSURs submitted under ‘old’ Volume 9A format. As the 

new format benefit-risk evaluation PSURs are introduced existing CSPs will not be 

required and therefore existing CSPs will not be updated. 

6 IMPLEMENTATION OF OUTCOMES 

6.1 Our product is a generic authorised under Article 10.1 and we will therefore not be 

involved in the next work sharing procedure for the active substance. How will we 

be informed of the outcome of the work sharing assessment? 

The outcome of the assessment will be published on the HMA web site. MAHs should 

review the information published and if as a result amendments are needed to their 

generic product, the appropriate variation should be submitted within 120 days. 


PSURs

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