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Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of
provisions laid down by Law, Regulation or Administrative Action relating to
proprietary medicinal products
Official Journal L 147 , 09/06/1975 p. 0013 - 0022
Greek special edition ....: Chapter 13 Volume 3 p. 66
Spanish special edition...: Chapter 13 Volume 4 p. 92
Portuguese special edition Chapter 13 Volume 4 p. 92
Finnish special edition....: Chapter 13 Volume 4 p. 98
Swedish special edition...: Chapter 13 Volume 4 p. 98
Amendments:
Amended by 383L0570
(OJ L 332 28.11.1983 p.1)
Amended by 389L0341
(OJ L 142 25.05.1989 p.11)
Derogation in 389L0342
(OJ L 142 25.05.1989 p.14)
Derogation in 389L0343
(OJ L 142 25.05.1989 p.16)
Derogation in 389L0381
(OJ L 181 28.06.1989 p.44)
See 392L0027
(OJ L 113 30.04.1992 p.8)
Amended by 393L0039
(OJ L 214 24.08.1993 p.22)
Incorporated by 294A0103(51)
(OJ L 001 03.01.1994 p.220)
Incorporated by 294A0103(52)
(OJ L 001 03.01.1994 p.263)
Amended by 300L0038
(OJ L 139 10.06.2000 p.28)
Text:
SECOND COUNCIL DIRECTIVE of 20 May 1975 on the approximation of provisions laid
down by law, regulation or administrative action relating to proprietary
medicinal products (75/319/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in
particular Article 100 thereof;
Having regard to the proposal from the Commission;
Having regard to the Opinion of the European Parliament (1);
Having regard to the Opinion of the Economic and Social Committee (2);
Whereas the approximation begun by Council Directive 65/65/EEC (3) of 26 January
1965 on the approximation of provisions laid down by law, regulation or
administrative action relating to proprietary medicinal products should be
continued and the implementation of the principles laid down in that Directive
should be ensured;
Whereas in order to reduce the disparities which remain, rules should be laid
down on the control of proprietary medicinal products and the duties incumbent
upon the Member States' competent authorities should be specified with a view to
ensuring compliance with legal requirements;
Whereas, in order to progress towards free movement of proprietary medicinal
products, the issue of authorizations to place one and the same proprietary
medicinal product on the market in two or more Member States should be
facilitated;
Whereas, for this purpose, a Committee for Proprietary Medicinal Products should
be set up, consisting of representatives of the Member States and of the
Commission, responsible for giving an opinion as to whether a particular
proprietary medicinal product complies with the requirements set out in
Directive 65/65/EEC;
Whereas this Directive represents merely one step towards achievement of the
objective of the free movement of proprietary medicinal products ; whereas,
therefore, further measures with a view to abolishing any remaining barriers to
the free movement of proprietary medicinal products will be necessary in the
light of experience gained, particularly in the abovementioned Committee;
Whereas in order to facilitate the movement of proprietary medicinal products
and to prevent the controls carried out in one Member State from being repeated
in another, minimum requirements should be laid down for manufacture and imports
coming from third countries and for the grant of the authorization relating
thereto;
Whereas it should be ensured that, in the Member States, the supervision and
control of the manufacture of proprietary medicinal products is carried out by a
person who fulfils minimum conditions of qualification;
Whereas, moreover, the provisions of this Directive and of that of Directive
65/65/EEC which relate to proprietary medicinal products, although appropriate,
are inadequate for vaccines, toxins and serums, proprietary medicinal products
based on human blood or blood constituents, proprietary medicinal products based
on radio-active isotopes and homeopathic proprietary medicinal products ;
whereas the application thereof should consequently not be imposed at the
present time in respect of such proprietary medicinal products;
Whereas certain rules in this Directive entail amendments to various provisions
of Directive 65/65/EEC,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I Application for authorization to place proprietary medicinal products
on the market
Article 1
Member States shall take all appropriate measures to ensure that the documents
and particulars listed (1)OJ No 96, 2.6.1965, p. 1677/65. (2)OJ No 107,
19.6.1965, p. 1825/65. (3)OJ No 22, 9.2.1965, p. 369/65.
in points 7 and 8 of Article 4, second paragraph, of Directive 65/65/EEC are
drawn up by experts with the necessary technical or professional qualifications
before they are submitted to the competent authorities. These documents and
particulars shall be signed by the experts.
Article 2
The duties of the experts according to their respective qualifications shall be:
(a) to perform tasks falling within their respective disciplines (analysis,
pharmacology and similar experimental sciences, clinical trials) and to describe
objectively the results obtained (qualitatively and quantitatively);
(b) to describe their observations in accordance with Council Directive
75/318/EEC (1) of 20 May 1975, on the approximation of the laws of the Member
States relating to analytical, pharmacotoxicological and clinical standards and
protocols in respect of the testing of proprietary medicinal products, and to
state, in particular: - in the case of the analyst, whether the product is
consistent with the declared composition, giving any substantiation of the
control methods employed by the manufacturer;
- in the case of the pharmacologist or the specialist with similar experimental
competence, the toxicity of the product and the pharmacological properties
observed;
- in the case of the clinician, whether he has been able to ascertain effects on
persons treated with the product which correspond to the particulars given by
the applicant in accordance with Article 4 of Directive 65/65/EEC, whether the
patient tolerates the product well, the posology the clinician advises and any
contra-indications and side-effects;
(c) where applicable, to state the grounds for using the published references
mentioned in point 8 (a) and (b) of Article 4, second paragraph, of Directive
65/65/EEC under the conditions set out in Directive 75/318/EEC.
Detailed reports by the experts shall form part of the particulars accompanying
the application which the applicant submits to the competent authorities.
Article 3
In the event of Article 2 of this Directive not being complied with, Article 5,
second paragraph, of Directive 65/65/EEC shall apply.
CHAPTER II Examination of the application for authorization to place proprietary
medical products on the market
Article 4
In order to examine the application submitted in accordance with Article 4 of
Directive 65/65/EEC, the competent authorities of the Member States: (a) must
verify whether the particulars submitted in support of the application comply
with the said Article 4 and examine whether the conditions for issuing an
authorization to place proprietary medicinal products on the market (marketing
authorization) are complied with;
(b) may submit the proprietary medicinal product for testing by a State
laboratory or by a laboratory designated for that purpose in order to ensure
that the control methods employed by the manufacturer and described in the
particulars accompanying the application in accordance with point 7 of Article
4, second paragraph, of Directive 65/65/EEC are satisfactory;
(c) may, where appropriate, require the applicant to supplement the particulars
accompanying the application in respect of the items listed in the second
paragraph of Article 4 of Directive 65/65/EEC. Where the competent authorities
avail themselves of this option, the time limits laid down in Article 7 of the
said Directive shall be suspended until such time as the supplementary
information required has been provided. Likewise, these time limits shall be
suspended for the time allowed the applicant, where appropriate, for giving oral
or written explanation.
Article 5
Member States shall take all appropriate measures to ensure that: (a) the
competent authorities verify that manufacturers and importers of products coming
from third countries are able to carry out manufacture in compliance with the
particulars supplied pursuant to point 4 of Article 4, second paragraph, of
Directive 65/65/EEC and/or to carry out controls according to the methods
described in the particulars accompanying the application in accordance with
point 7 of Article 4, second paragraph, of that Directive; (1)See page 1 of this
Official Journal.
(b) the competent authorities may allow manufacturers and importers of products
coming from third countries, in exceptional and justifiable cases, to have
certain stages of manufacture and/or certain of the controls referred to in (a)
carried out by third parties ; in such cases, the verifications by the competent
authorities shall also be made in the establishment designated.
Article 6
Where a leaflet is enclosed with the packaging of a proprietary medicinal
product Member States shall take all appropriate measures to ensure that it
applies to the product in question only.
All the information given in the leaflet must be in accordance with the
particulars and documents supplied pursuant to Article 4 of Directive 65/65/EEC
and must be approved by the competent authorities.
The leaflet must include at least the following information: (a) name and
domicile or corporate name and domicile or registered place of business of the
person responsible for marketing the product and, where applicable, of the
manufacturer;
(b) name and qualitative and quantitative particulars of the product in terms of
its active ingredients.
The international non-proprietary names recommended by the World Health
Organization should be used where such names exist;
(c) in the absence of a decision to the contrary by the competent authorities: -
therapeutic indications,
- contra-indications, side effects and special precautions for use.
Information and decisions under the first and second indents shall take into
account the results of the clinical trials and pharmacological tests provided
for in point 8 of Article 4, second paragraph, of Directive 65/65/EEC and in the
case of the information referred to under the second indent, of experience
acquired in use after marketing;
(d) directions for use of the product (method of administration, duration of
treatment if this should be limited, normal dosage);
(e) special storage precautions, where applicable.
Other information shall be clearly separate from that referred to above.
Member State may require that a leaflet be included with the packaging.
Article 7
Notwithstanding the provisions of Chapter IV and of Article 21 of Directive
65/65/EEC, Member States may require that the proprietary medicinal product
shall be labelled so as to indicate on the container and/or outer packaging and/or
on the package leaflet other requirements essential to safety or for the
protection of public health, including any particular precautions to be taken in
using the product and any other warnings based on the results of the clinical
trials and pharmacological tests mentioned in point 8 of Article 4, second
paragraph, of Directive 65/65/EEC, or resulting from experience in the course of
use of the proprietary medicinal product after marketing.
CHAPTER III Committee for Proprietary Medicinal Products
Article 8
1. In order to facilitate the adoption of a common position by the Member States
regarding marketing authorizations, a Committee for Proprietary Medicinal
Products, hereinafter referred to as "the Committee", is hereby set up.
The Committee shall consist of representatives of the Member States and of the
Commission.
2. The responsibility of the Committee shall be to examine, in accordance with
Articles 9 to 14, the questions referred to it by a Member State concerning the
application of Articles 5, 11 or 20 of Directive 65/65/EEC.
3. The Committee shall draw up its own Rules of Procedure.
Article 9
1. The Member State which has issued a marketing authorization for a proprietary
medicinal product shall forward to the Committee a dossier containing a copy of
the authorization together with the particulars and documents specified in
Article 4, second paragraph, of Directive 65/65/EEC, if the person responsible
for marketing has requested the forwarding to at least five other Member States.
2. The Committee shall forthwith forward the dossier to the competent
authorities of the Member States so specified.
3. Such forwarding shall be deemed to be equivalent to submitting an application
for marketing authorization, within the meaning of Article 4 of Directive
65/65/EEC, to the said authorities.
Article 10
1. If, within a period of 120 days after the date of the forwarding referred to
in Article 9 (2), no objection is notified to the Committee by the competent
authorities of the Member States specified, the Committee shall formally record
the fact and forthwith inform the Member States concerned.
2. Where a Member State considers that it is unable to authorize the marketing
of the proprietary medicinal product, it shall forward its reasoned objection,
within the said period of 120 days, on the basis of Article 5 of Directive
65/65/EEC.
Article 11
1. In the cases referred to in Article 10 (2), the Committee shall consider the
matter and give a reasoned opinion within not more than 60 days from the expiry
of the time limit laid down in Article 10.
2. The opinion of the Committee shall deal with the compliance of the
proprietary medicinal product with the conditions set out in Article 5 of
Directive 65/65/EEC.
The Committee shall forthwith inform the Member States concerned of its opinion
or, in the event of a divergence, of the opinions of its members.
3. The Member States concerned shall reach a decision on the application for
marketing authorization not more than 30 days after the date on which the
information provided for in Article 10 (1) or paragraph 2 of this Article is
given. They shall forthwith inform the Committee of their decision.
Article 12
1. If several applications submitted in accordance with Article 4 of Directive
65/65/EEC have been made for marketing authorization for a particular
proprietary medicinal product, and one or more Member States have granted an
authorization while one or more of the other Member States have refused it, one
of the Member States concerned may bring the matter before the Committee.
The same shall apply where one or more Member States have suspended or revoked
the marketing authorization while one or more other Member States have not done
so.
2. The Committee shall consider the matter and give a reasoned opinion within
120 days at the most.
3. The opinion of the Committee shall only deal with the grounds on which
authorization was refused, suspended or revoked.
The Committee shall forthwith inform the Member States concerned of its opinion
or, in the event of a divergence, of the opinions of its members.
4. The Member States concerned shall give notice within 30 days of the action
they intend to take following the Committee's opinion.
Article 13
The Committee may set a time limit for a fresh examination on the basis of
particulars relating to the conditions laid down in Articles 5, 11 or 20 of
Directive 65/65/EEC obtained in the meantime by the Member States, in particular
by those which have authorized the proprietary medicinal product.
Article 14
The competent authorities of Member States may, in specific cases where the
interests of the Community are involved, refer the matter to the Committee
before reaching a decision on an application for a marketing authorization, its
suspension or revocation.
Article 15
1. The Commission shall report to the Council annually on the operation of the
procedure laid down in this Chapter and its effects on the development of
intra-Community trade. It shall report for the first time two years after the
entry into force of this Directive.
2. In the light of experience the Commission shall, not later than four years
after the entry into force of this Directive, submit to the Council a proposal
containing appropriate measures leading towards the abolition of any remaining
barriers to the free movement of proprietary medicinal products. The Council
shall take a decision on the Commission proposal no later than one year after
its submission.
CHAPTER IV Manufacture and imports coming from third countries
Article 16
1. Member States shall take all appropriate measures to ensure that the
manufacture of the proprietary medicinal products is subject to the holding of
an authorization.
2. The authorization referred to in paragraph 1 shall be required for both total
and partial manufacture, and for the various processes of dividing up, packaging
or presentation.
However, such authorization shall not be required for preparation, dividing up,
changes in packaging or presentation where these processes are carried out,
solely for retail supply, by pharmacists in dispensing pharmacies or by persons
legally authorized in the Member States to carry out such processes.
3. Authorization referred to in paragraph 1 shall also be required for imports
coming from third countries into a Member State ; this Chapter and Article 29
shall have corresponding application to such imports as they have to manufacture.
Article 17
In order to obtain the authorization referred to in Article 16, the applicant
must meet at least the following requirements: (a) specify the proprietary
medicinal products and pharmaceutical forms which are to be manufactured or
imported and also the place where they are to be manufactured and/or controlled;
(b) have at his disposal, for the manufacture or import of the above, suitable
and sufficient premises, technical equipment and control facilities complying
with the legal requirements which the Member State concerned lays down as
regards both manufacture and control and the storage of products, in accordance
with Article 5 (a).
(c) have at his disposal the services of at least one qualified person within
the meaning of Article 21.
The applicant must provide particulars in support of the above in his
application.
Article 18
1. The competent authority of the Member State shall issue the authorization
referred to in Article 16 only after having made sure of the accuracy of the
particulars supplied pursuant to Article 17, by means of an inquiry carried out
by its agents.
2. In order to ensure that the requirements referred to in Article 17 are
complied with, authorization may be made conditional on the carrying out of
certain obligations imposed either when authorization is granted or at a later
date.
3. The authorization shall apply only to the premises specified in the
application and to the proprietary medicinal products and pharmaceutical forms
specified in that same application.
Article 19
The holder of an authorization referred to in Article 16 shall at least be
obliged: (a) to have at his disposal the services of staff who comply with the
legal requirements existing in the Member State concerned both as regards
manufacture and controls;
(b) to dispose of the authorized proprietary medicinal products only in
accordance with the legislation of the Member States concerned;
(c) to give prior notice to the competent authority of any changes he may wish
to make to any of the particulars supplied pursuant to Article 17 ; the
competent authority shall in any event be immediately informed if the qualified
person referred to in Article 21 is replaced unexpectedly;
(d) to allow the agents of the competent authority of the Member State concerned
access to his premises at any time;
(e) to enable the qualified person referred to in Article 21 to carry out his
duties, for example by placing at his disposal all the necessary facilities.
Article 20
1. The Member States shall take all appropriate measures to ensure that the time
taken for the procedure for granting the authorization referred to in Article 16
does not exceed 90 days from the day on which the competent authority receives
the application.
2. If the holder of the authorization requests a change in any of the
particulars referred to in Article 17 (a) and (b), the time taken for the
procedure relating to this request shall not exceed 30 days. In exceptional
cases this period of time may be extended to 90 days.
3. Member States may require from the applicant further information concerning
the particulars supplied pursuant to Article 17 and concerning the qualified
person referred to in Article 21 ; where the competent authority concerned
exercises this right, application of the time limits referred to in paragraphs 1
and 2 shall be suspended until the additional data required have been supplied.
Article 21
1. Member States shall take all appropriate measures to ensure that the holder
of the authorization referred to in Article 16 has permanently and continuously
at his disposal the services of at least one qualified person, in accordance
with the conditions laid down in Article 23, responsible in particular for
carrying out the duties specified in Article 22.
2. If he personally fulfils the conditions laid down in Article 23, the holder
of the authorization may himself assume the responsibility referred to in
paragraph 1.
Article 22
1. Member States shall take all appropriate measures to ensure that the
qualified person referred to in Article 21, without prejudice to his
relationship with the holder of the authorization referred to in Article 16, is
responsible, in the context of the procedures referred to in Article 25, for
securing: (a) in the case of proprietary medicinal products manufactured within
the Member States concerned that each batch of proprietary 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
authorization;
(b) in the case of proprietary medicinal products coming from third countries,
that each production batch has undergone in the importing country 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 proprietary medicinal products in accordance with the requirements of the
marketing authorization.
The batches of products which have undergone such controls in a Member State
shall be exempt from the above controls if they are imported into another Member
State, accompanied by the control reports signed by the qualified person.
A Member State may relieve the qualified person of responsibility for the
controls prescribed under (b) for imported proprietary medicinal products which
are to remain in that Member State, if appropriate arrangements have been made
with the exporting country to ensure that those controls have been carried out
in the exporting country. Where these products are imported in the packaging in
which they are to be sold by retail, Member States may allow exceptions to the
requirements laid down in Article 17.
2. In all cases and particularly where the proprietary 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.
Article 23
Member States shall ensure that the qualified person referred to in Article 21
fulfils the following minimum conditions of qualification: (a) 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 (a) 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:
Applied physics
General and inorganic chemistry
Organic chemistry
Analytical chemistry
Pharmaceutical chemistry, including analysis of medicinal products
General and applied biochemistry (medical)
Physiology Microbiology
Pharmacology
Pharmaceutical technology
Toxicology
Pharmacognosy (medical aspects) (study of the composition and effects of the
active principles of natural 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 22.
In so far as certain diplomas, certificates or other evidence of formal
qualifications mentioned in (a) do not fulfil the criteria laid down above, the
competent authority of the Member State shall ensure that the person concerned
provides evidence of adequate knowledge of the subjects involved.
(b) Practical experience for at least two years, in one or more undertakings
which are authorized to manufacture proprietary 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 proprietary 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.
Article 24
1. A person engaging in the activities of the person referred to in Article 21
in a Member State at the time when this Directive is brought into force in that
State but without complying with the provisions of Article 23 shall be eligible
to continue to engage in those activities in the State concerned.
2. The holder of a diploma, certificate or other evidence of formal
qualifications awarded on completion of a university course - or a course
recognized as equivalent by the Member State concerned - in a scientific
discipline allowing him to engage in the activities of the person referred to in
Article 21 in accordance with the laws of that State may - if he began his
course prior to the notification of this Directive - be considered as qualified
to carry out in that State the duties of the person referred to in Article 21
provided that he has previously engaged in the following activities for at least
two years before the end of the tenth year following notification of this
Directive in one or more undertakings authorized pursuant to Article 16 :
production supervision and/or qualitative analysis, quantitative analysis of
active substances, and the necessary testing and checking under the direct
authority of the person referred to in Article 21 to ensure the quality of the
proprietary medicinal products.
If the person concerned has acquired the practical experience referred to in the
first subparagraph more than 10 years prior to the notification of this
Directive, a further one year's practical experience in accordance with the
conditions referred to in the first subparagraph will be required to be
completed immediately before he engages in such activities.
3. A person who, at the time when this Directive is brought into force, is
engaged in direct collaboration with a person referred to in Article 21 in
production supervision activities and/or in qualitative and quantitative
analysis of active substances and the testing and checking necessary to ensure
the quality of proprietary medicinal products may, for a period of five years
after this Directive has been brought into force, be considered as qualified to
take up in that State the duties of the person referred to in Article 21
provided that that Member State ensures that the person shows evidence of
adequate theoretical and practical knowledge and has engaged in the activities
mentioned for at least five years.
Article 25
Member States shall ensure that the duties of qualified persons referred to in
Article 21 are fulfilled, either by means of appropriate administrative measures
or by making such persons subject to a professional code of conduct.
Member States may provide for the temporary suspension of such a person upon the
commencement of administrative or disciplinary procedures against him for
failure to fulfil his obligations.
CHAPTER V Supervision and sanctions
Article 26
The competent authority of the Member State concerned shall ensure by means of
inspections that the legal requirements relating to proprietary medicinal
products are complied with.
Such inspections shall be carried out by officials representing the competent
authority who must be empowered to: (a) inspect manufacturing or commercial
establishments and any laboratories entrusted by the holder of the authorization
referred to in Article 16 with the task of carrying out checks pursuant to
Article 5 (b);
(b) take samples;
(c) examine any documents relating to the object of the inspection, subject to
the provisions in force in the Member States at the time of notification of this
Directive and which place restrictions on these powers with regard to the
descriptions of the method of preparation.
Article 27
Member States shall take all appropriate measures to ensure that the person
responsible for marketing a proprietary medicinal product and, where
appropriate, the holder of the authorization referred to in Article 16, furnish
proof of the controls carried out on the finished product and/or the ingredients
and of the controls carried out at an intermediate stage of the manufacturing
process, in accordance with the methods laid down for the purposes of the
marketing authorization.
Article 28
1. Notwithstanding the measures provided for in Article 11 of Directive
65/65/EEC, Member States shall take all appropriate measures to ensure that the
supply of the proprietary medicinal product shall be prohibited and the
proprietary medicinal product withdrawn from the market if: (a) the proprietary
medicinal product proves to be harmful under normal conditions of use;
(b) it is lacking in therapeutic efficacy;
(c) its qualitative and quantitative composition is not as declared;
(d) the controls on the finished product and/or on the ingredients and the
controls at an intermediate stage of the manufacturing process have not been
carried out or if some other requirement or obligation relating to the grant of
the authorization referred to in Article 16 has not been fulfilled.
2. The competent authority may limit the prohibition to supply the product, or
its withdrawal from the market, to those batches which are the subject of
dispute.
Article 29
1. The competent authority of a Member State shall suspend or revoke the
authorization referred to in Article 16 for a category of preparations or all
preparations where any one of the requirements laid down in Article 17 is no
longer met.
2. In addition to the measures specified in Article 28, the competent authority
of a Member State may suspend manufacture or imports of proprietary medicinal
products coming from third countries, or suspend or revoke the authorization
referred to in Article 16 for a category of preparations or all preparations
where Articles 18, 19, 22 and 27 are not complied with.
CHAPTER VI Miscellaneous provisions
Article 30
Member States shall take all appropriate measures to ensure that the competent
authorities concerned communicate to each other such information as is
appropriate to guarantee that the requirements for the authorizations referred
to in Article 16 or marketing authorizations are fulfilled.
Article 31
All decisions taken pursuant to Articles 18, 28 and 29 and all negative
decisions taken pursuant to Articles 5 (b) and 11 (3) shall state in detail the
reasons on which they are based. Such decisions shall be notified to the party
concerned, who shall at the same time be informed of the remedies available to
him under the laws in force and of the time limit allowed for applying for such
remedies.
Article 32
No decision concerning suspension of manufacture or of importation of
proprietary medicinal products coming from third countries, prohibition of
supply or withdrawal from the market of a proprietary medicinal product may be
taken except on the ground set out in Articles 28 and 29.
Article 33
Each Member State shall take all the appropriate measures to ensure that
decisions authorizing marketing, refusing or revoking a marketing authorization,
cancelling a decision refusing or revoking a marketing authorization,
prohibiting supply, or withdrawing a product from the market, together with the
reasons on which such decisions are based, are brought to the attention of the
Committee forthwith.
Article 34
This Directive shall apply only to proprietary medicinal products for human use.
Chapters II to V of Directive 65/65/EEC and this Directive shall not apply to
proprietary medicinal products consisting of vaccines, toxins or serums, to
proprietary medicinal products based on human blood or blood constituents or
radioactive isotopes, or to homeopathic proprietary medicinal products. A list,
for information purposes, of these vaccines, toxins and serums is given in the
Annex.
Article 35
The following shall be substituted for point 7 of Article 4, second paragraph,
of Directive 65/65/EEC:
"Description of the control methods employed by the manufacturer
(qualitative and quantitative analysis of the constituents and of the finished
product, special tests, e.g. sterility tests, tests for the presence of
pyrogenic substances, the presence of heavy metals, stability tests, biological
and toxicity tests, controls carried out at an intermediate stage of the
manufacturing process)."
Article 36
The following shall be substituted for Article 11, second paragraph, of
Directive 65/65/EEC:
"An authorization shall also be suspended or revoked where the particulars
supporting the application as provided for in Article 4 are found to be
incorrect, or when the controls referred to in Article 8 of this Directive or in
Article 27 of the Second Council Directive 75/319/EEC (1) of 20 May 1975 on the
approximation of provisions laid down by law, regulation or administrative
action relating to proprietary medicinal products have not been carried
out."
The following footnote shall be added:
Article 37
The following shall be substituted for Article 24 of Directive 65/65/EEC:
"Within the time limits and under the conditions laid down in Article 39
(2) and (3) of second Directive 75/319/EEC, the rules laid down in this
Directive shall be applied progressively to proprietary medicinal products
covered by an authorization to place on the market by virtue of previous
provisions".
CHAPTER VII Implementing provisions and transitional measures
Article 38
Member States shall bring into force the laws, regulations and administrative
provisions needed in order to comply with this Directive within 18 months of its
notification and shall forthwith inform the Commission thereof.
Member States shall communicate to the Commission the text of the main
provisions of national law which they adopt in the field covered by this
Directive.
Article 39
1. As regards the authorizations referred to in Article 16 issued before the
expiry of the time limit laid down in Article 38, Member States may grant an
additional period of one year to the undertakings concerned to enable them to
comply with the provisions of Chapter IV.
2. Within 15 years of the notification referred to in Article 38, the other
provisions of this Directive shall be applied progressively to proprietary
medicinal products placed on the market by virtue of previous provisions.
3. Member States shall notify the Commission, within three years following the
notification of this Directive, of the number of proprietary medicinal products
covered by paragraph 2, and, each subsequent year, of the number of these
products for which a marketing authorization referred to in Article 3 of
Directive 65/65/EEC, has not yet been issued.
Article 40
This Directive is addressed to the Member States.
Done at Brussels, 20 May 1975.
For the Council
The President
R. RYAN "(1) OJ No L 147, 9.6.75, p. 13."
ANNEX
The expression "vaccines, toxins or serums" used in Article 34 shall
cover in particular: - agents used to produce active immunity
(such as cholera vaccine, BCG, polio vaccine, smallpox vaccine);
- agents used to diagnose the state of immunity
including in particular tuberculin and tuberculin PPD, toxins for the Schick and
Dick Tests, brucellin;
- agents used to produce passive immunity
(such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic
globulin). Source: EUR-Lex
Community Legislation in force-Document 375L0319 |
Anthroposophic
Medicine