Medicinal products marketing

authorization procedures

https://www.regulatory-affairs.pl/en/medicinal-products.html
 The basic principles of EU law

• The main types of EU legal acts

– Regulations (Regulation) - do not require implementation -
apply to all countries, even if there are no such records in
national law
– Directives – not obligatory by itself, but the Member States
have an obligation to implement these provisions into
national law
– Scientific and procedural guidelines published by the
working groups within the EMA ICH, EC, CMD

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 The basic principles of EU law

• Basic legislation for medicinal products

– Directive 2001/83, as amended - regulates the
requirements for human medicinal products including
marketing authorization procedures, dossier (introduced
CTD format), the types of applications (so called legal basis
- for example generic, hybrid, WEU, fixed combination),
introduces the European Pharmacopoeia (Ph. Eur./EP) as a
source of basic quality requirements
– Directive 2001/82, as amended - the equivalent of the
above for veterinary medicinal products

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 The basic principles of EU law

• Basic legislation for medicinal products

– Regulation 726/2003, as amended - establishes the
European Medicines Agency EMA (formerly EMEA)
responsible for the central procedure and the coordination
of EU-wide projects (including coordination of the
development of scientific guidelines and procedural
cooperation of national agencies etc.).
– Directive 2003/94 on EU GMP
– Regulation 1234/2008 introducing a new system of post-
marketing variations the MRP, DCP and the central
procedure

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 Marketing authorization procedures

• National procedure
• Mutual Recognition Procedure MRP
• Decentralized procedure DCP
• Central procedure

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 National procedure

• Marketing authorization of a medicinal product in

single EU country
• Dossier assessment in single country
• Regulated by national legislation of particular
country

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 National procedure

• Timeline: 210 days + clock-stop periods (suspension

of the process for the preparation of answers to
questions)
• The first stage is a formal validation of the
application and documentation (fees, completeness
attached documents etc.)
• After successful completion of this stage the dossier
is directed to the proper assessment of data

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 MRP (mutual recognition procedure)

• Applicable if the medicinal product is already

registered in one of the EU countries and company
wants to authorize it in the next EU
country/countries
• Formally mandatory if the same product has already
been authorized (the same MAH and the same
composition) in one of EU countries - the aim is the
common assessment and as a result the same SmPC

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 MRP (mutual recognition procedure)

• A common assessment by all involved countries (so

called CMS - Concerned Member States)
• Country in which the product is already authorized
acts as the RMS (Reference Member State). RMS is
responsible for procedure management and
preparation of the assessment report for the
procedure
• The assessment report and the medicinal product
dossier is then assessed by the CMSs

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 MRP (mutual recognition procedure)

• General principles MRP procedures are defined by the

Directive 2001/83
• Timeline of the procedure: 90 days. Preceded by a three-
month period to prepare an assessment report by the RMS
and CMS 14-day validation stage for CMS countries which is
similar to the national procedure validation procedure (fees,
completeness of dossiers, and formal documents)
• Important: there are no clock-stop periods - little time to
prepare the answers.

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 DCP procedure

• The same medicinal product is to be authorized in parallel in

several EU countries, and it has not been authorized in the EU
yet.
• One of these countries is selected as the RMS country which
is responsible for preparation of the preliminary assessment
report while the rest of involved countries (CMSs) jointly
review the assessment report and the medicinal product
dossier
• Timeline: 210 days + clock-stops
• It’s now the most common procedure for marketing
authorization in the EU

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 Central procedure

• The most complicated and most demanding procedure

• Single assessment and single license issued by the European
Commission on the basis of EMA assessment valid in all EU
member states.
• Assessment by chosen countries selected from CHMP or
CVMP members.

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 Central procedure

• This procedure is mandatory for new therapies for HIV / AIDS,

neurodegenerative diseases (eg. Alzheimer's disease), cancer,
diabetes, and medicinal products which use recombinant DNA
techniques.
• The procedure is very expensive and demanding in terms of
dossier, studies and procedural issues.
• Calendar of procedure: 210 days with clock-stop periods,
similar to the DCP calendar.

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