Legal Basis for Qualified Persons in Europe.
The Legal Basis for the Qualified Person is defined in the
OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 6 NOVEMBER 2001 ON THE COMMUNITY CODE RELATING TO MEDICINAL PRODUCTS FOR HUMAN USE.
For Veterinary Products, the requirements are defined in
DIRECTIVE 2001/82/EC of the European Parliament and of the Council of
6 November 2001 on the Community code relating to veterinary medicinal
In Article 48, the Directive 2001/83 (for veterinary medicinal products,
please read Article 52 of Directive 2001/82) requests that EU Member
States have to assure that each holder of a manufacturing authorization
has to have at least one QP.
1. Member States shall take all appropriate measures to ensure that the
holder of the manufacturing authorization has permanently and continuously
at his disposal the services of at least one qualified person, in
accordance with the conditions laid down in Article 49, responsible in
particular for carrying out the duties specified in Article 51.
2. If he personally fulfils the conditions laid down in Article 49, the
holder of the authorization may himself assume the responsibility referred
to in paragraph 1.
In Article 49 of Directive 2001/83 (for veterinary medicinal products,
please read Article 53 of Directive 2001/82), the qualification level as
well as the necessary experience of a QP is defined
Member States shall ensure that the qualified person referred to in Article 48 fulfils the minimum
conditions of qualification set out in paragraphs 2 and 3.
A qualified person shall be in possession of a diploma, certificate or other evidence of formal
qualifications awarded on completion of a university course of study, or a course recognized as equivalent
by the Member State concerned, extending over a period of at least four years of theoretical and practical
study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry,
pharmaceutical chemistry and technology, biology. However, the minimum duration of the university course
may be three and a half years where the course is followed by a period of theoretical and practical
training of a minimum duration of one year and including a training period of at least six months in a
pharmacy open to the public, corroborated by an examination at university level. Where two university
courses or two courses recognized by the State as equivalent co-exist in a Member State and where one
of these extends over four years and the other over three years, the three-year course leading to a diploma,
certificate or other evidence of formal qualifications awarded on completion of a university course or its
recognized equivalent shall be considered to fulfil the condition of duration referred to in the second
subparagraph in so far as the diplomas, certificates or other evidence of formal qualifications awarded
on completion of both courses are recognized as equivalent by the State in question. The course shall
include theoretical and practical study bearing upon at least the following basic subjects:
General and inorganic chemistry
including analysis of medicinal products
General and applied biochemistry (medical)
Pharmacognosy (study of the composition and effects of the natural active substances of plant and animal origin).
Studies in these subjects should be so balanced as to
enable the person concerned to fulfil the obligations specified in Article
In so far as certain diplomas, certificates or other evidence of formal
qualifications mentioned in the first subparagraph do not fulfil the
criteria laid down in this paragraph, the competent authority of the
Member State shall ensure that the person concerned provides evidence of
adequate knowledge of the subjects involved.
3. The qualified person shall have acquired practical experience over at
least two years, in one or more undertakings which are authorized to
manufacture medicinal products, in the activities of qualitative analysis
of medicinal products, of quantitative analysis of active substances and
of the testing and checking necessary to ensure the quality of medicinal
products. The duration of practical experience may be reduced by one year
where a university course lasts for at least five years and by a year and
a half where the course lasts for at least six years.
The responsibilities of a Qualified Person are defined in Article 51 of
Directive 2001/83 (for veterinary medicinal products, please read Article 55 of
1. Member States shall take all appropriate measures to
ensure that the qualified person referred to in Article 48, without
prejudice to his relationship with the holder of the manufacturing
authorization, is responsible, in the context of the procedures referred
to in Article 52, for securing:
(a) in the case of medicinal products manufactured within the Member
States concerned, that each batch of medicinal products has been
manufactured and checked in compliance with the laws in force in that
Member State and in accordance with the requirements of the marketing
(b) in the case of medicinal products coming from third countries, that
each production batch has undergone in the importing Member State a full
qualitative analysis, a quantitative analysis of at least all the active
constituents and all the other tests or checks necessary to ensure the
quality of medicinal products in accordance with the requirements of the
marketing authorization. The batches of medicinal products which have
undergone such controls in a Member State shall be exempt from the
controls if they are marketed in another Member State, accompanied by the
control reports signed by the qualified person.
2. In the case of medicinal products imported from a third country, where
appropriate arrangements have been made by the Community with the
exporting country to ensure that the manufacturer of the medicinal product
applies standards of good manufacturing practice at least equivalent to
those laid down by the Community, and to ensure that the controls referred
to under point (b) of the first subparagraph of paragraph 1 have been
carried out in the exporting country, the qualified person may be relieved
of responsibility for carrying out those controls.
3. In all cases and particularly where the medicinal products are released
for sale, the qualified person must certify in a register or equivalent
document provided for that purpose, that each production batch satisfies
the provisions of this Article; the said register or equivalent document
must be kept up to date as operations are carried out and must remain at
the disposal of the agents of the competent authority for the period
specified in the provisions of the Member State concerned and in any event
for at least five years.
The following Guidances contain further requirements for the tasks to be
fulfilled by a Qualified Person in Europe
EU GMP Guide to Good Manufacturing Practices
Annex 16 to the EU Guide to Good Manufacturing Practice Certification by a Qualified Person and Batch Release