TITLE III

PLACING ON THE MARKET
CHAPTER 1

Marketing authorization
Article 8
1
In order to obtain an authorization to place a medicinal product on the market regardless of the procedure established by Regulation (EEC) No 2309/93, an application shall be made to the competent authority of the Member State concerned.
2
A marketing authorization may only be granted to an applicant established in the Community.
3
The application shall be accompanied by the following particulars and documents, submitted in accordance with Annex I:
a
Name or corporate name and permanent address of the applicant and, where applicable, of the manufacturer.
b
Name of the medicinal product.
c
Qualitative and quantitative particulars of all the constituents of the medicinal product, including the reference to its international non-proprietary name (INN) recommended by the WHO, where an INN for the medicinal product exists, or a reference to the relevant chemical name.
ca
Evaluation of the potential environmental risks posed by the medicinal product. This impact shall be assessed and, on a case-by-case basis, specific arrangements to limit it shall be envisaged.
d
Description of the manufacturing method.
e
Therapeutic indications, contra-indications and adverse reactions.
f
Posology, pharmaceutical form, method and route of administration and expected shelf life.
g
Reasons for any precautionary and safety measures to be taken for the storage of the medicinal product, its administration to patients and for the disposal of waste products, together with an indication of potential risks presented by the medicinal product for the environment.
h
Description of the control methods employed by the manufacturer.
ha
A written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of the active substance with principles and guidelines of good manufacturing practice by conducting audits, in accordance with point (f) of Article 46. The written confirmation shall contain a reference to the date of the audit and a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of good manufacturing practice.
i
Results of:
- pharmaceutical (physico-chemical, biological or microbiological) tests,
- pre-clinical (toxicological and pharmacological) tests,
- clinical trials.
ia
A summary of the applicant’s pharmacovigilance system which shall include the following elements:
- proof that the applicant has at his disposal a qualified person responsible for pharmacovigilance,
- the Member States in which the qualified person resides and carries out his/her tasks,
- the contact details of the qualified person,
- a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Title IX,
- a reference to the location where the pharmacovigilance system master file for the medicinal product is kept.
iaa
The risk management plan describing the risk management system which the applicant will introduce for the medicinal product concerned, together with a summary thereof.
ib
A statement to the effect that clinical trials carried out outside the European Union meet the ethical requirements of Directive 2001/20/EC.
j
A summary, in accordance with Article 11, of the product characteristics, a mock-up of the outer packaging, containing the details provided for in Article 54, and of the immediate packaging of the medicinal product, containing the details provided for in Article 55, together with a package leaflet in accordance with Article 59.
k
A document showing that the manufacturer is authorised in his own country to produce medicinal products.
l
Copies of the following:
- any authorisation, obtained in another Member State or in a third country, to place the medicinal product on the market, a summary of the safety data including the data contained in the periodic safety update reports, where available, and suspected adverse reactions reports, together with a list of those Member States in which an application for authorisation submitted in accordance with this Directive is under examination;
- the summary of the product characteristics proposed by the applicant in accordance with Article 11 or approved by the competent authorities of the Member State in accordance with Article 21 and the package leaflet proposed in accordance with Article 59 or approved by the competent authorities of the Member State in accordance with Article 61;
- details of any decision to refuse authorisation, whether in the Union or in a third country, and the reasons for such a decision.
m
A copy of any designation of the medicinal product as an orphan medicinal product under Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products
, accompanied by a copy of the relevant Agency opinion.
n
Proof that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country.
The documents and information concerning the results of the pharmaceutical and pre-clinical tests and the clinical trials referred to in point (i) of the first subparagraph shall be accompanied by detailed summaries in accordance with Article 12.
The risk management system referred to in point (iaa) of the first subparagraph shall be proportionate to the identified risks and the potential risks of the medicinal product, and the need for post-authorisation safety data.
The information referred to in the first subparagraph shall be updated where and when appropriate.
OJ L 18, 22.1.2000, p. 1 .
Substituted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Inserted by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Text with EEA relevance).
Substituted by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance).
Deleted by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance).
Inserted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Inserted by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance).