Referrals, referrals, referrals . . . - TOPRA

focus 

Focus 

2 

The TOPRA 

Referrals, 

2nd North America 

Annual Symposium Meeting Report 

referrals, referrals . . . 

Authors 

Anne Lenihan (Pfizer Ltd, Tadworth, Surrey, UK), Vincent Wek 

(Bluefinch, London, UK), Karen Cox (Pfizer Ltd, Tadworth, Surrey, UK) 

Introduction 

This article aims to discuss the different Community referral 

procedures, which are summarised in Table 1. The Referral procedures 

are described under Articles 32, 33 and 34 of Directive 2001/83/EC, 

as amended. 

Speakers 

to central EU assessment by the CHMP. While the central assessment 

Key words 

brings with it harmonisation Dombroski, of product and Chris information, Griffett. the majority 

Monique Garrett (Octagon Research Solutions, Inc, Pennsylvania, USA) of with nationally-approved products 

The meeting 

still remain 

was co-chaired 

disharmonised 

by Susanne 

in this 

Arbitration, referrals, harmonisation 

contributions from Carlos Langezaal (Sanofi-Aventis, New Jersey, USA), respect due to historical 

Dorn, 

divergent 

Amylin 

national 

Pharmaceuticals 

decisions. One 

and 

way 

Dr 

of 

Susanne Dorn (Amylin, California, USA), Paolo Biffignandi (VI.REL Pharma, achieving Italy) harmonisation and is through referral procedures and Directive 

Abstract 

Paolo Biffignandi, VI.REL Pharma S.r.l. Italy 

Christopher Bailey (TOPRA) 

2001/83/EC, as amended, provides the legal basis for binding 

and member of the Board of Directors of 

Pharmaceutical legislation has created a binding Community arbitration mechanisms. 

TOPRA. The usual housekeeping rules were 

arbitration mechanism which may be implemented on the basis 

These referral procedures mentioned, involve scientific and the evaluation morning by session the CHMP, was 

of the following articles: 1, 2 

This second TOPRA leading North to a America single opinion, started. which subsequently forms the basis of a 

Article 29 of Directive 2001/83/EC as amended Symposium, – initiated was well binding attended single EC Decision by across the Community. 

Paediatric Regulation: 

because of disagreement between Member approximately States in the 40 delegates and speakers 

A perspective from the European 

from the European 

Procedural 

Medicines Agency 

guidance for referrals 

Mutual Recognition Framework, 

4 

Medicines Agency 

(EMEA), the United States The main of procedural America activities for all types of referral are summarised 

Article 30 of Directive 2001/83/EC as amended – initiated 

Food and Drug Administration Table 2. (FDA) Clear practical and Dr guidance Natalie is Seigneuret provided in (EMEA) Chapters 3 and 6 of 

in order to obtain harmonisation of divergent decisions 

various pharmaceutical the companies, Notice to CROs, Applicants. Dr The Seigneuret national procedures spoke to about be followed Paediatric by 

within the Community for products already authorised, 

etc. The topics for this the symposium individual Member were States Regulations following and supporting a Commission activities Decision occurring are 

Article 31 & 36 of Directive 2001/83/EC Paediatric as amended Regulations in 

given 

the 

in 

morning 

Chapter 

and 

7, of the at Notice the EMEA. to Applicants. She noted that the objective 

– initiated where the interests of the Community Risk Management are involved Plans in Whatever the afternoon, the opinion and (positive of the regulation, or negative), which the scientific came into conclusions force in relation to safety/risk to public health, the scientific portion of on the each day referral was closed (generated January by the 26, EMEA) 2007, was are focused provided on in improving Annexes 

Article 35 of Directive 2001/83/EC as amended out with – a initiated round table to discussion the CHMP with opinion. the health of children by increasing the quality, 

mainly because of disagreement between presenters Member States and industry representatives. ethical research into medicines for children 

Possibility of appeal 4 

and increasing the availability of authorised 

a Type IB or Type II variation, 

Opening remarks 

When the MAH disagrees medicines with the for CHMP children, opinion, without the MAH delaying has 

Article 107(2) of Directive 2001/83/EC as Dr amended Carlos – Langezaal, the as TOPRA’s possibility North to appeal authorisation no later than for 15 adults. days after Natalie receipt described of the 

initiated to obtain a CHMP opinion further America to the suspension Head opened CHMP the 2007 opinion. North After this four date, key no “pillars” appeal of is the possible regulation: and the opinion 

or revocation of the Marketing Authorisation America of a medicinal Annual Symposium is considered by welcoming as agreed. The appeal procedure allows the applicant 60 

product in a Member State as a result of pharmacovigilance 

Paediatric Committee (PDCO) is to be 

the delegates and speakers. days to He forward introduced the grounds for appeal to the EMEA. The CHMP has 

data. 3 

established by July 26, 2007. This committee 

TOPRA as a global a further organisation 60 days for to consider the appeal and adopt a final opinion. 

includes CHMP members, patient, family 

regulatory professionals and for those who 

Whichever article applies the matter is referred to the Committee From reviewing the overall and healthcare referral data professionals, from the EMEA experts referral from 

have an interest in Regulatory Affairs in the 

for Medicinal Products for Human Use (CHMP) for a scientific database, concluded between national February competent 1995 authorities and May and EEA. 2007 5 , it 

healthcare sector. The current 

appears 

membership 

that there have been no cases of appeal to a referral as yet. 

evaluation. The resulting CHMP opinion forms the 

is drawn 

basis of 

from 

a 

over 50 countries. Effective Paediatric Investigation Plan (PIP) – An 

binding European Commission (EC) Decision. regulatory professionals The need European to get Commission the applicant Decisionmust 4 submit a request for PIP 

In addition, there is Article 5(3) of Regulation 726/2004 right information – initiated delivered The at final the CHMP right level opinion is at forwarded end of Phase in I all unless the European duly justified.This official 

to obtain a CHMP opinion on any scientific matter the raised right by time, the and languages, that’s what accompanied TOPRA by milestone the CHMP requires Scientific early Conclusion, dialog and the to 

EMEA, the European Commission or a Member provides State, 3 through although its educational the Member programme, States, the EC need and the for applicant. procedures Based for on modifications the CHMP 

this does not result in a binding decision from the including EC. symposia like Scientific today. Subsequently, Opinion the EC will are then foreseen issue as its with Decision. amendments. The Member The 

Carlos introduced TOPRA’s States North addressed, America should adopt PIP the must EC define Decision the within overall 30 strategy days of for its 

paediatric development by the applicant. 

TOPRA – The Organisation for Professionals in Regulatory Affairs 

Over the last ten years there has been a shift in the assessment and 

registration of human medicinal Team members, products, Susanne from national Dorn, Gillian assessments Ivers-

Focus 

3 

Table 1: Community Referral Overview 4 

Article of 

2001/83/EEC 

as amended 

29 

30 

31 

35 

Referral type 

“Mutual Recognition 

referral” 

“Divergent decision 

referral” 

“Community interest 

referral” 

Who may start 

referral? 

MS concerned 

by MRP 

Any MS, EC or 

MAH 

Any MS, EC or 

MAH 

Which parties are 

concerned? 

All MS involved in the 

MRP (RMS and CMSs) 

All MS where MA 

granted, refused, 

suspended, withdrawn 

All MS (MA granted, 

refused, withdrawn) 

“Follow up referral” MS or MAH All MS involved in the 

MRP (RMS and CMSs) 

Can application be withdrawn or 

referral stopped? 

MAH may withdraw at any time. 

However, the CHMP may continue 

under an Article 31 procedure 

regardless of the MAH withdrawal 

MAH may withdraw from all 

markets at any time 



procedure regardless of the MAH 

withdrawal 



the procedure regardless of the 

MAH withdrawal 

36 “Follow up referral” MS or MAH All MS where MA is 

authorised 



the procedure regardless of the 

MAH withdrawal 

WAINWRIGHT_TOPRA_half:WAINWRIGHT_TOPRA_half 27/4/2007 12:00 Page 1 

MS = Member State, MAH = Marketing Authorisation Holder, CMSs = Concerned Member States, RMS = Reference Member State, MRP = Mutual Recognition Procedure 

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Regulatory Rapporteur – September Issue 2007

Focus 

4 

Table 2: Referral – Standard Timetable 4 

Day 0 • Notification of a referral to the CHMP 

Day 1 • CHMP meeting to discuss and adopt questions to be addressed in the referral 

• Appointment of the Rapporteur/(Co) – Rapporteur 

Clock stop • For the applicant(s)/Marketing Authorisation Holder(s) to answer the list of questions raised by the CHMP 

Clock re-start (day 2) • First CHMP meeting after submission of responses 

• Adoption by the CHMP of timetable for the rest of the procedure. (Potential negotiation for response time) 

Day 45 • (Co)-Rapporteur(s) prepare(s) assessment reports 

Day 55 • Comments from the CHMP members on the (Co)-Rapporteur(s) assessment report(s) 

Day 60 • Discussion at the CHMP 

• Need to have an oral explanation: (Co)-Rapporteur(s) and EMEA to liaise with the applicant(s)/Marketing 

Authorisation Holder(s) 

• Applicant(s)/Marketing Authorisation Holder(s) should submit the translations of draft SmPC in all EU 

official languages 

Clock stop • If necessary, for the preparation and submission of oral explanations 

Clock re-start • If necessary, oral explanations 

Day 90 • Adoption of the CHMP opinion 

notification. The Decision is also transmitted to the Member States 

not involved in the procedure for information. 

The countries with national licences, if applicable, should take appropriate 

measures to harmonise their authorisation and SmPC with the one 

approved by the EC. The EC Decision is binding to all addresses. 

Overview and discussion of the different referrals 

This section will discuss each of the different referral procedures 

separately. Details of all completed referrals can be accessed from 

the EMEA referral website. 5 

Article 29 “Mutual Recognition referral” 

Arbitration procedures under Article 29 of Directive 2001/83/ 

EC, as amended are initiated because of disagreement between 

Member States during the Mutual-Recognition Procedure (MRP) 

or Decentralised Procedure (DCP). 4 A Member State that cannot 

approve an authorisation within a MRP/DCP procedure may, under 

Article 29, refer the matter for consideration to the Coordination 

Group for Mutual Recognition and Decentralised Procedures – 

Human (CMD(h)). 6 The grounds for the referral must be “on the 

basis of potential serious risk to public health”. 7 

A referral to the CMD(h) was introduced with the aim of creating a 

procedure that would prevent the need for arbitration by the CHMP. 

Prior to this, issues raised often remained unresolved because the 

applicant withdrew the application in the disagreeing Member State. 

Now, even if an application is withdrawn, a claim of a serious risk to 

public health must be investigated by the CMD(h). 6 

If the issues cannot be resolved by the CMD(h) then the matter is 

referred for arbitration by the CHMP, which then follows the usual 

referral procedure. Member States that are willing to accept the 

RMS position can grant a Marketing Authorisation for the product 

concerned without prejudice to the outcome of the referral. 

Article 30 “Divergent decision referral” 

If Member States have adopted divergent decisions concerning the 

authorisation of a particular medicinal product or its suspension or 

withdrawal from the market, a Member State, or the Commission, 

or the Marketing Authorisation Holder may refer the matter to 

the CHMP under Article 30 of Directive 2001/83/EC as amended. 

The CHMP will then issue an opinion which aims to resolve the 

divergences between the national decisions. 4 

SmPC harmonisation 

The remit for SmPC harmonisation came about following the implementation 

of Directive 2001/83/EC, as amended. Article 30(2) of 

EU Directive 2001/83/EC as amended, which provides the basis for 

SmPC harmonisation, states that “In order to promote harmonisation 

of authorisations for medicinal products authorised in the Community, 

Member States shall, each year, forward to the coordination group a 

list of medicinal products for which a harmonised summary of product 

characteristics should be drawn up”. The CMD(h) Sub-group on 

Harmonisation of SmPCs has been given the mandate by this article to 8 : 

1. Advise Member States in choosing products suitable for harmonisation 

by giving examples of criteria to be used. 

2. Recommend to CMD which products, suggested by Member 

States, should be included in the list of medicinal products for 

which a harmonised SmPC should be drawn up 

3. Have contact with interested parties, in an appropriate way and 

time, to ensure that their views will be considered 

TOPRA – The Organisation for Professionals in Regulatory Affairs

Focus 

5 

4. Be a forum for discussions with the EC on which party will make 

the referral for which product, the order and timing for referrals 

and the practical arrangements such as a pre-referral meeting 

with MAH/EMEA etc. 

The criteria for selection of products for SmPC harmonisation was 

endorsed by the CMD(h) during its January 2006 meeting and is as 

follows 9 : 

Significant differences in core parts of the SmPC (Sections 4.1- 4.4) 

 

 

 

Exclusivity/patent expiry dates, which are linked to entry of 

generic products 

Extent of the use of the product 

Number of MS where the product is authorised. 

Once every year the list of products for SmPC harmonisation drawn 

up by the CMD(h), is forwarded to the EU Commission. 10 Before 

a referral is triggered under Article 30(2), the list of products for 

proposed harmonisation is made publicly available for comments 

from interested parties to be taken into account. 

Article 31 “Community interest referral” 

In specific cases where the interests of the Community are involved, 

a Member State, or the Commission, or the Marketing Authorisation 

Holder may refer the matter to the CHMP under an Article 31 of 

Directive 2001/83/EC as amended, before taking a decision on a request 

for a Marketing Authorisation, or on the suspension, or withdrawal of 

a Marketing Authorisation or on any other variation to the terms 

of a Marketing Authorisation which appears necessary. The CHMP 

will then issue an Opinion on the concerns raised in the questions 

involving Community interests. The Decision of the Commission must 

In the majority of Article 31 cases from the EMEA website this 

referral procedure has been used for matters relating to drug safety 

issues and sometimes involve all medicinal products belonging to one 

therapeutic class. 5 

Article 35 “Follow up referral” 

Arbitration procedures under Article 35 of Directive 2001/83/ 

EC, as amended are initiated because of disagreement between 

Member States during a Type IB or Type II variation procedure. 

Article 35 provides for an Article 5(11), 6(12) or 6(13) referral 

under Commission Regulation No 1084/2003. Article 5(11) and 

Article 6(13) are for situations where a Type IB or Type II variation, 

respectively, is refused and Article 6(12) where a Member State does 

not consider it possible to mutually recognise a Type II variation. 4 

Article 36 “Follow up referral” 

In specific cases where a change/variation, suspension or withdrawal 

of a harmonised Marketing Authorisation is necessary for the 

protection of public health, a Member State may refer the matter to 

the CHMP under Article 36 of Directive 2001/83/EC as amended. 4 

Article 5(3) “Scientific matter referral” and Article 107(2) “Pharmacovigilance 

referral” 

Within this paper Article 5(3) and Article 107(2) procedures will not 

be discussed in detail, due to the fact that these referral procedures are 

new legislative tools and the experience in 2006 has been very limited. 

Referrals under Article 5(3) of Regulation 726/2004 are initiated to 

obtain a CHMP opinion on any scientific matter raised by the EMEA, 

the European Commission or a Member State. 3 It does not result in 

a binding decision of the European Commission. 

be implemented in all Member States concerned. 4 Regulatory Rapporteur – September Issue 2007 

Figure 1: Completed Referrals from May 1996 to May 2007 5 

20 

15 

No. of Articles 

10 

Article 36 

Article 35 

Article 31 

Article 30 

Article 29 

5 

0 

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Focus 

6 

Referrals under Article 107(2) under Directive 2001/83/EC as 

amended are initiated to obtain a CHMP Opinion further to the 

suspension or revocation of the Marketing Authorisation of a medicinal 

product in a Member State as a result of pharmacovigilance data. It 

is expected that referrals relating to pharmacovigilance concerns will 

concern therapeutic classes rather than individual products. 3 

EMEA Referral database analysis 5 

This section provides a summary of Articles 29, 30, 31, 35, and 36 from the 

EMEA referral database concluded between May 1996 and May 2007. 5 

From the graphical representation (Figure 1) there has been a 

substantial increase in referrals in 2000, 2002 and again in 2006, 

particularly Article 29 and 30 of Directive 2001/83/EC as amended. 

The main reasons for the increase in referrals include: 

• SmPC harmonisation project (2001 – Heads of Agencies, CMD(h)) 

• Ongoing activities of the Pharmacovigilance Working Party 

• Shift of regulatory environment from national to pan-European 

• Increased focus on the benefit/risk profile of products. 

Further analysis of Articles 29, 30, 31, 35, and 36 referrals from the 

EMEA referral database was conducted which is shown in Table 3. 5 

From reviewing the data the following was observed for each of the 

referrals: 

• Article 29 Referrals – a total of 33 completed. A review of the 

data showed the median duration was 8 months, the shortest was 

6 months, and the longest was 18 months (see Figure 2). 


data showed the median duration was 15 months, the shortest 

was 8 months and, the longest was 24 months (see Figure 2). 



was 7 months and the longest was 37 months (see Figure 2). 



was 5 months, and the longest was 19 months (see Figure 2). 

• Article 36 Referrals – a total of 3 completed. A review of the data 

showed the median duration was 11 months, the shortest was 8 

months, and the longest was 43 months (see Figure 2). 

In summary, the duration for the different types of referrals varied 

due to the complexities of the issues raised. Overall, the data show 

that in 11 years from May 1996 to May 2007 there have been a total 

of 94 referrals procedures concluded (see Table 3), and that Article 

31 and Article 36 referrals took longer to resolve followed closely by 

Article 30 referrals. 5 

Table 3: Summary of Completed Referrals from May 1996 to May 2007 5 

Counts 

Year of Completion 

Article 29 Article 30 Article 31 Article 35 Article 36 Total 

1996 1 4 5 

1997 1 1 2 

1998 1 1 2 

1999 1 1 2 

2000 2 1 3 6 

2001 1 1 

2002 2 5 2 3 12 

2003 3 8 2 3 16 

2004 4 4 5 3 16 

2005 4 1 5 1 11 

2006 13 4 1 2 20 

2007 1 1 

Grand Total 33 24 22 12 3 94 


Focus 

7 

Figure 2: Duration of the Different Referrals from May 1996 to May 2007 5 

45 

40 

35 

30 

Months 

25 

20 

Minimum 

Median 

Maximum 

15 

10 

5 

0 

Article 29 Article 30 Article 31 Article 35 Article 36 

Overall practical aspect for managing a referral 

Box 1 highlights some overall practical aspects for managing a referral procedure. 

Box 1 

Overall practical aspects 

 

 

Develop a good relationship with your designated EMEA 

Product Team Leader (PTL) and Administrator. This is 

essential and will help the process to go smoothly. 

Seek clarity on all the steps in the referral procedure. 

Upon initiation of a referral 

In certain circumstances, for example Article 30, 31 

and 36, Marketing Authorisation Holders (MAHs) can 

group together to submit a single response. In these 

circumstances the following applies: 

Each MAH must provide a signed Letter of 

Representation allowing a single contact to act on their 

behalf. 

The products covered by the referral will be provided in 

a list from the EMEA (designated as Annex 1). 

A single fee may be payable to the EMEA. 11 

During the referral 

 

 

 

 

It is useful to generate and maintain a chronological 

summary of events throughout the procedure. 

For older products consider that it may be more challenging 

to respond to EMEA questions within the timelines, due to 

locating all relevant historical data. 

For complex issues there exists an opportunity for 

applicants to have an Oral Explanation (OE) with the 

CHMP. 

Ensure the accuracy of Annex 1 particulars (eg, List of the 

Invented Names, pharmaceutical forms, strengths of the 

medicinal products, route of administration and Marketing 

Authorisation Holders in the Member States), as this is 

legally binding following the EC Decision. 

Regulatory Rapporteur – September Issue 2007

Focus 

8 

Box 1 continued 

Upon completion of a referral 

The decision-making process (from CHMP Opinion to 

Commission Decision) is the same as for the Centralised 

Procedure. 

Be prepared for the translations into all the EU official 

languages. 

MAHs can liaise with each other to provide a single version of 

the translated Annexes to the EMEA. 

Once a referral is finalised, consider external communications, 

eg, press releases, and updates to promotional materials. 

It may be necessary to disseminate a Direct Healthcare 

Professional Communication or other educational materials in 

accordance with Volume 9A of the Rules Governing Medicinal 

Products in the EU. 

The EMEA may request MAHs to collaborate on certain 

documents to finalise the referral. 

After completion of a referral, the MA should enter into 

a procedure that allows the MAH to improve and/or 

develop the product further in a harmonised manner. These 

recommendations are outlined in the MRFG guidance 

document on “Recommendations for MRP after finalisation of 

an arbitration procedure…” 12 . 

Conclusion 

automatic referral of Article 29 arbitrations and 

continue to increase, due to: 3 

With the ever increasing focus on continued positive benefit: risk 

profiles of medicinal products, referral procedures provide a 

framework to address safety matters in a pan-European way. From 

reviewing the EMEA referral database, referrals have increased over 

the years, especially Article 29 and Article 30. Due to complexities of 

the particular referral procedure the referral duration can be as short 

as 5 months and as long as 43 months (see Figure 2). 

References 

In the immediate future referrals are here to stay and will probably 

continue to increase. The number of Article 29 and 30 referrals will 

Special Interest 

Groups 

Are you in the food and feed 

additives industry and preparing 

for REACH ? 

TOPRA is aware that regulations of the food 

and feed additives industry are becoming more 

complex. There has been interest expressed in 

creating an email network for TOPRA members 

working in regulatory affairs in the area, in order to 

provide a forum for the discussion and exchange of 

information and experiences in this changing field. 

If you would be interested in becoming a member 

of the network, send your details to: 

spin@topra.org 

the legislative requirement for the CMD(h) to prepare an annual 

list of medicinal products for harmonisation (ie, Article 30s). 

It will be interesting to observe whether there will be further 

increases in referrals as more experienced is gained with Article 5(3) 

and Article 107(2). 

1. Directive 2001/83/EC of the European Parliament and of the 

Council of November 6, 2001 on the Community Code Relating to 

Medicinal Product for human use http://www.emea.europa.eu/pdfs/ 

human/pmf/2001-83-EC.pdf (accessed June 18, 2007). 

2. Annual Report of the European Medicines Agency (2006) www. 

emea.europa.eu/pdfs/general/direct/emeaar/EMEA_Annual_Report_ 

2006_full.pdf (accessed June 18, 2007). 

3. EMEA Work Programme 2007 – http://www.emea.europa.eu/htms/ 

general/direct/wp.htm (accessed June 18, 2007). 

4. Notice to Applicants http://ec.europa.eu/enterprise/ 

pharmacWalcot56euticals/eudralex/homev2.htm (accessed June 18, 

2007). 

5. EMEA Referral website – extensive list of referred applications to 

date http://www.emea.europa.eu/htms/human/referral/referral.htm 

(accessed June 18, 2007). 

6. CMD(h) Referrals – http://www.hma.eu/26.html (accessed June 18, 

2007). 

7. Guideline on the definition of a potential serious risk to public health 

in the context of Article 29(1) and (2) of Directive 2001/83/EC 

– March 2006 http://eurlex.europa.eu/LexUriServ/site/en/oj/2006/ 

c_133/c_13320060608en00050007.pdf (accessed June 18, 2007). 

8. SmPC Harmonisation mandate htp://www.hma.eu/uploads/media/ 

SG_SPC_harmon_mandate.pdf (accessed June 18, 2007). 

9. CMD (h) Sub-Group on Harmonisation of SmPCs http://www.hma. 

eu/uploads/media/SG_SPC_harmo_selection_criteria.pdf (accessed 

June 18, 2007). 

10. CMD(h) List of Products for SmPC Harmonisation 2006 http://hma. 

eu/uploads/media/CMD_product_list_SPC_Harmonisation_2006.pdf 

(accessed June 18, 2007). 

11. Explanatory Note on Fees Payable to the EMEA http://www.emea. 

europa.eu/htms/human/presub/39418705en.pdf (accessed June 18, 

2007). 

12. Recommendation for Mutual Recognition Procedure after finalisation 

of an arbitration procedure with a Positive Opinion by the CPMP 

and a Positive Decision by the EU Commission http://www.hma. 

eu/uploads/media/rec_arbitration.pdf (accessed June 18, 2007).

Referrals, referrals, referrals . . . - TOPRA

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