1985L0433 — EN — 01.01.1995 — 003.001 — 1
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►B COUNCILDIRECTIVE
of16September1985
concerningthemutualrecognitionofdiplomas,certificatesandotherevidenceofformalqualifica-
tions in pharmacy, including measures to facilitate the effective exercise of the right of
establishmentrelatingtocertain activities inthefieldofpharmacy
(85/433/EEC)
(OJ L 253, 24.9.1985, p. 37)
Amended by:
Official Journal
No page date
►M1Council Directive 85/584/EEC of 20 December 1985 L 372 42 31.12.1985
►M2Council Directive 90/658/EEC of 4 December 1990 L 353 73 17.12.1990
Amended by:
►A1Act of Accession of Austria, Sweden and Finland C241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
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COUNCILDIRECTIVE
of16September1985
concerning the mutual recognition of diplomas, certificates and
other evidence of formal qualifications in pharmacy, includingmeasurestofacilitatetheeffectiveexerciseoftherightofestablish-
mentrelating tocertain activities inthefieldofpharmacy
(85/433/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Articles 49 and 57 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the European Parliament(2),
Having regard to the opinion of the Economic and Social
Committee(3),
Whereas, pursuant to the Treaty, all discriminatory treatment based on
nationality withregard to establish ment and provision of services isprohibited as from the end of the transitional period; whereas the prin-ciple of suchtreatment based on nationality applies, in particular, to th e
grant of any authorization required for the practice of certain activities,
and also to registration withor membersh ip of professional organiza-tions or bodies;
Whereas it nevertheless seems desirable that certain provisions be
introduced to facilitate the effective exercise of the right of establish-
ment;
Whereas, pursuant to Article 54 (3) (h) of the Treaty, the Member
States are required not to grant any form of aid likely to distort theconditions of establishment;
Whereas Article 57 (1) of the Treaty provides that Directives be
adopted for mutual recognition of diplomas, certificates and other
evidence of formal qualifications;
Whereas, in view of the present disparities in training in pharmacy
given in the Member States, it is necessary to lay down certain coordi-nating provisions to enable the Member States to introduce mutualrecognition of diplomas, certificates and other evidence of formal
qualifications; whereas such coordination has been established by
Council Directive 85/432/EEC of 16 September 1985, concerning thecoordination of provisions laid down by law, regulation or administra-tive action in respect of certain activities in the field of pharmacy(
4);
Whereas in certain Member States access to certain activities in the
field of pharmacy is, apart from the award of the relevant diploma,
certificate or other formal qualification, subject to the requirement ofadditional professional experience; whereas, since there is as yet noconvergence of views among the Member States on this point, it isadvisable, in order to obviate any difficulties, to recognize as a suffi-cient condition appropriate practical experience of equal duration
acquired in another Member State;
Whereas, under their national policies in the sphere of public health,
which seekinter alia to ensure the satisfactory dispensing of medicinal
products over their entire territories, certain Member States restrict thenumber of new pharmacies that may be established, while others have
adopted no such provisions; whereas in these circumstances it is
premature to provide that the effects of the recognition of diplomas,certificates and other evidence of formal qualifications in pharmacy1985L0433 — EN — 01.01.1995 — 003.001 — 2
(1) OJ No C 35, 18. 2. 1981, p. 6 and OJ No C 40, 18. 2. 1984, p. 4.
(2) OJ No C 277, 17. 10. 1983, p. 160.
(3) OJ No C 230, 10. 9. 1981, p. 10.
(4) See page 34 of this Official journal.
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must also extend to the pursuit of the activities of pharmacist as the
controller of a pharmacy open to the public for less than three years;whereas this problem must be re-examined by the Commission and
the Council within a certain period;
Whereas, with regard to the possession of a formal certificate of
training, since a Directive on the mutual recognition of diplomas doesnot necessarily imply equivalence in the training covered by suchdiplomas, the use of such qualifications should be authorized only inthe language of the Member State of origin or of the Member Statefrom which the foreign national comes;
Whereas, to facilitate the application of this Directive by the national
authorities, Member States may prescribe that, in addition to formal
certificates of training, the person who satisfies the conditions of
training required by this Directive must provide a certificate from thecompetent authorities of his country of origin or of the country fromwhich he comes stating that these certificates of training are thosecovered by the Directive;
Whereas this Directive does not affect the provisions laid down by law,
regulation or administrative action in the Member States which prohibit
companies from practising certain activities or impose on them certain
conditions for suchpractice;
Whereas it is difficult to assess the extent to which rules aimed at facil-
itating freedom of pharmacists to provide services could at present beappropriate; whereas, in these circumstances, it is not advisable toadopt suchrules for th e time being;
Whereas, with regard to good character and good repute, a distinction
should be drawn between the requirements to be satisfied on firsttaking up the profession and those to be satisfied in order to practise it;
Whereas, as far as the activities of employed persons are concerned,
Council Regulation (EEC) No 1612/68 of 15 October 1968 on freedomof movement for workers within the Community(
1) lays down no
specific provisions relating to good character or good repute, profes-
sional discipline or use of title for the professions covered; whereas,depending on the individual Member State, such rules are or may beapplicable both to employed and self-employed persons; whereas theactivities subject in the Member States to possession of a diploma,
certificate or other evidence of formal qualification in pharmacy are
pursued by bothemployed and self-employed persons, or by th e samepersons in both capacities in the course of their professional career;whereas, in order to encourage as far as possible the free movementof those professional persons within the Community, it thereforeappears necessary to extend the application of this Directive to
employed persons.
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
Scope
Article 1
This Directive applies to activities, the access to and pursuit of which
is subject to conditions of professional qualification in one or moreMember States, and which are open to holders of one of the diplomas,certificates or other formal qualifications in pharmacy referred to inArticle 4.1985L0433 — EN — 01.01.1995 — 003.001 — 3
(1) OJ No L 257, 19. 10. 1968, p. 2.
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CHAPTER II
Diplomas,certificatesandotherevidenceofformalqualificationsin
pharmacy
Article 2
1. Each Member State shall recognize the diplomas, certificates and
other formal qualifications listed in Article 4 awarded to nationals ofMember States by other Member States in accordance with Article 2of Directive 85/432/EEC by giving suchqualifications, as regards th e
right of access to and pursuit of the activities referred to in Article 1,
the same effect in its territory as those diplomas, certificates and otherformal qualifications, listed in Article 4, which it itself awards.
2. However, Member States need not give effect to the diplomas,
certificates and other formal certificates referred to in paragraph 1with respect to the establishment of new pharmacies open to the public.For the purposes of applying this Directive, pharmacies which havebeen in operation for less than three years shall also be regarded asnew.
Five years after the date stipulated in Article 19 (1), the Commission
shall submit a report to the Council on the way in which MemberStates have implemented the preceding subparagraph and on the possi-
bility of extending the effects of mutual recognition of the diplomas,
certificates and other formal certificates referred to in paragraph 1. Itshall make any appropriate proposals.
Article 3
1. By way of derogation from Article 2 and without prejudice to
Article 45 of the 1979 Act of Accession, the Hellenic Republic shallnot be required to give effect as laid down in Article 2 to the diplomas,certificates and other formal qualifications awarded by other Member-
States except in the case of the pursuit as an employed person in accor-
dance withRegulation (EEC) No 1612/68 of th e activities referred toin Article 1.
As long as the Hellenic Republic makes use of this derogation and
without prejudice to Article 45 of the 1979 Act of Accession, the other
Member States shall not be required to give effect as provided for inArticle 2 to the certificates referred to in Article 4 (d) except in thecase of the pursuit as an employed person in accordance with Regula-tion (EEC) No 1612/68 of the activities referred to in Article 1.
2. Ten years after the date stipulated in Article 19, the Commission
shall submit to the Council appropriate proposals in order to extend theeffects of mutual recognition of diplomas, certificates and other formalqualifications with a view to facilitating the effective exercise of the
right of establishment between the Hellenic Republic and the other
Member States. The Council shall act on these proposals in accordancewith the procedure laid down in the EEC Treaty.
Article 4
The diplomas, certificates and other evidence of formal qualifications
referred to in Article 2 are the following:
(a)in Belgium:
Le diplôme légal de pharmacien/het wettelijk diploma van
apoteker (the legal diploma in pharmacy) awarded by the faculties
of medicine and pharmacy of the Universities, by the Centralexamining board or by the State examining boards for universityeducation;
(b)in Denmark:
Bevis for bestået farmaceutisk kandidateksamen (the university
pharmacy certificate);1985L0433 — EN — 01.01.1995 — 003.001 — 4
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(c)in the Federal Republic of Germany:
►M2 ◄Zeugnis über die staatliche Pharmazeu-
tische Prüfung (the State examination certificate in pharmacy)
awarded by the competent authorities;
(d)in Greece:
Πιατοποιητκό των αρµοδίων αρχών, ικανότητας άσκησης της
φαρµακευτιτκής, χορηγουµενο µετά κρατική εξέταση ( the
certificate attesting competence to pursue the activity of a pharma-cist) issued by the competent authorities following a Stateexamination;
(e)in France:
The State diploma in pharmacy awarded by the universities or the
State diploma of Doctor in Pharmacy awarded by the universities;
(f)in Ireland:
The certificate of Registered Pharmaceutical Chemist;
(g)in Italy:
The diploma or certificate giving the right to practise pharmacy,
obtained by passing a State examination;
(h)in Luxembourg:
The State pharmacy diploma awarded by the State Examining
Board and signed by the National Minister of Education;
(i)in the Netherlands:
Het getuigschrift van met goed gevolg afgelegd apothekersexamen
(the university pharmacy certificate);
(j)in the United Kingdom:
The certificate of Registered Pharmaceutical Chemist ;
(k)in Spain:
Título de licenciado en farmacia (university degree in pharmacy
awarded by the Ministry of Education and Science or by theuniversities);
(l)in Portugal:
Carta de curso de licenciatura em Ciências Farmacêuticas (the
certificate in pharmaceutical sciences awarded by the universities);
(m)in Austria:
Staatliches Apothekerdiplom (State diploma of pharmacists)
awarded by the competent authorities;
(n)in Finland:
todistus proviisorin tutkinnosta — bevis om provisorexamen
(Master of Science in Pharmacy) awarded by a university;
(o)in Sweden:
apotekarexamen (university diploma in pharmacy) awarded by the
University of Uppsala.
Article 5
Where, in a Member State, access to or pursuit of one of the activities
referred to in Article 1 is subject not only to the possession of a
diploma, certificate or other formal qualification mentioned in Article4 but also to the requirement of additional professional experience,that State shall accept as sufficient evidence in this respect a certificateissued by the competent authorities of the person's Member State of1985L0433 — EN — 01.01.1995 — 003.001 — 5
▼M2
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▼M1
▼A1
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origin or of the Member State from which he comes, attesting that he
has pursued the said activities for an equivalent period in his MemberState of origin or in the Member State from which he comes.
However, such recognition shall not apply with regard to the two-year
period of professional experience required by the Grand Duchy ofLuxembourg for the grant of a State public pharmacy concession.
CHAPTER III
Establishedrights
Article 6
►M21.◄Diplomas, certificates and other university or equiva-
lent qualifications in pharmacy which were awarded to nationals of
Member States by Member States and which do not satisfy all theminimum training requirements laid down in Article 2 of Directive85/432/EEC shall be treated as diplomas satisfying these requirementsif:
— they are evidence of training which was completed before the
implementation of the said Directive, or
— they are evidence of training which was completed after but which
was commenced before the implementation of the said Directive,
and, in eachcase, if:
— they are accompanied by a certificate stating that their holders have
been effectively and lawfully engaged in one of the activities
referred to in Article 1 (2) of Directive 85/432/EEC in a MemberState for at least three consecutive years during the five yearspreceding the award of the certificate, provided that this activity isregulated in that State.
2. Diplomas, certificates and other university or equivalent qualifica-
tions in pharmacy which were awarded to nationals of Member Statesby Member States and which satisfy all the minimum training require-
ments laid down in Article 2 of Directive 85/432/EEC but which do
not conform to the designations set out in Article 4 shall be treated,for the purposes of the Directive, as the diplomas set out in that Articleif they are accompanied by a certificate stating that they attest totraining conforming to the provisions of Directive 85/432/EEC referredto in Article 2 of this Directive and shall be treated by the Member
States which awarded them as those designations are set out in Article
4 of this Directive.
Article 6a
Diplomas, certificates and other university or equivalent qualifications
in pharmacy which attest to training received by nationals of the
Member States on the territory of the former German Democratic
Republic and which do not satisfy all the minimum training require-ments laid down in Article 2 of Directive 85/432/EEC shall be treatedas diplomas satisfying these requirements if:
— they attest to training commenced before German unification,
— they entitle the holder to pursue the activities of pharmacist
throughout the territory of Germany under the same conditions asthe qualifications awarded by the competent German authoritiesand referred to in Article 4 (c), and
— they are accompanied by a certificate stating that their holders have
effectively and lawfully been engaged in Germany in one of theactivities referred to in Article 1 (2) of Directive 85/432/EEC forat least three consecutive years during the five years prior to thedate of issue of the certificate, provided that such activity is regu-lated in the Member State in question.1985L0433 — EN — 01.01.1995 — 003.001 — 6
▼M2
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CHAPTER IV
Useofacademic title
Article 7
1. Without prejudice to Article 14, host Member States shall ensure
that nationals of Member States who fulfil the conditions laid down inArticles 2, 5 and 6 have the right to use the lawful academic title and,
where appropriate, the abbreviation thereof, of their Member State of
origin or of the Member State from which they come, in the languageof that State. Host Member States may require this title to be followedby the name and location of the establishment or examining boardwhich awarded it.
2. If the academic title used in the Member State of origin, or in the
Member State from which a foreign national comes, can be confused inthe host Member State with a title requiring in that State additionaltraining which the person concerned has not undergone, the host
Member State may require sucha person to use th e title employed in
the Member State of origin or the Member State from which he comesin suitable wording to be indicated by the host Member State.
CHAPTER V
Provisions to facilitate the effective exercise of the right of estab-
lishment
Article 8
1. A host Member State which requires of its nationals proof of
good character or good repute when they take up for the first timeany of the activities referred to in Article 1 shall accept as sufficientevidence, in respect of nationals of other Member States, a certificate
issued by a competent authority in the Member State of origin or in
the Member State from which the foreign national comes, attestingthat the requirements of the Member State as to good character orgood repute for taking up the activity in question have been met.
2. Where the Member State of origin or the Member State from
which the foreign national comes does not require proof of good char-acter or good repute of persons wishing to take up the activity inquestion for the first time, the host Member State may require ofnationals of the Member State of origin or of the Member State fromwhich the foreign national comes an extract from the judicial record or,
failing this, an equivalent document issued by a competent authority in
the Member State of origin or the Member State from which theforeign national comes.
3. If the host Member State has detailed knowledge of a serious
matter which, prior to the establishment in that State of the person in
question, has occurred outside its territory and is likely to affect thetaking up within its territory of the activity concerned, it may informthe Member State of origin or the Member State from which theforeign national comes. The Member State of origin or the MemberState from which the foreign national comes shall verify the accuracy
of the facts if they are likely to affect the taking up of the activity in
question in that Member State. The authorities in that State shall decideon the nature and extent of the investigations to be made and shallinform the host Member State of any consequential action which theytake with regard to the certificates or documents they have issued.
4. Member States shall ensure the confidentiality of the information
which is forwarded.
Article 9
1. Where, in a host Member State, provisions laid down by law,
regulation or adminsitrative action are in force laying down require-ments as to good character or good repute, including provisions fordisciplinary action in respect of serious professional misconduct orconviction for criminal offences and relating to the pursuit of any of1985L0433 — EN — 01.01.1995 — 003.001 — 7
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the activities referred to in Article 1, the Member State of origin or the
Member State from which the foreign national comes shall forward tothe host Member State all necessary information regarding measures or
disciplinary action of a professional or administrative nature taken in
respect of the person concerned, or criminal penalties imposed on himwhen pursuing his profession in the Member State of origin or in theMember State from which he came.
2. If the host Member State has detailed knowledge of a serious
matter which, prior to the establishment in that State of the person inquestion, has occurred outside its territory and is likely to affect the
pursuit within its territory of the activity concerned, it may inform the
Member State of origin or the Member State from which the foreignnational comes. The Member State of origin or the Member Statefrom which the foreign national comes shall verify the accuracy of thefacts if they are likely to affect in that Member State the pursuit of theactivity in question. The authorities in that State shall decide on the
nature and extent of the investigations to be made and shall inform
the host Member State of any consequential action which they takewith regard to the information they have forwarded in accordancewithparagraph1.
3. Member States shall ensure the confidentiality of the information
which is forwarded.
Article 10
Where a host Member State requires of its own nationals wishing to
take up or pursue any of the activities referred to in Article 1, a certi-ficate of physical or mental health, that State shall accept as sufficientevidence thereof the presentation of the document required in theMember State of origin or in the Member State from which the foreign
national comes.
Where the Member State of origin or the Member State from which the
foreign national comes does not impose any requirements of this nature
on those wishing to take up or pursue the activity in question, the hostMember State shall accept from such nationals a certificate issued by acompetent authority in that State corresponding to the certificatesissued in the host Member State.
Article 11
The documents referred to in Articles 8, 9 and 10 may not be presented
more than three months after their date of issue.
Article 12
1. The procedure for authorizing the person concerned to take up
any of the activities referred to in Article 1, pursuant to Articles 8, 9
and 10, must be completed as soon as possible and not later than threemonths after submission of all the documents relating to such person,without prejudice to delays resulting from any appeal that may bemade upon the completion of this procedure.
2. In the cases referred to in Articles 8 (3) and 9 (2), a request for
re-examination shall suspend the period stipulated in paragraph l.
When consulted, the Member State of origin or the Member State from
which the foreign national comes shall give its reply within threemonths.
On receipt of the reply or at the end of that period, the host Member
State shall continue with the procedure referred to in paragraph 1.
Article 13
Where a host Member State requires its own nationals wishing to take
up or pursue one of the activities referred to in Article 1 to take an oathor make a solemn declaration and where the form of such oath ordeclaration cannot be used by nationals of other Member States, that1985L0433 — EN — 01.01.1995 — 003.001 — 8
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Member State shall ensure that an appropriate and equivalent form of
oathor declaration is offered to th e persons concerned.
Article 14
Where in a host Member State, the use of the professional title relating
to one of the activities referred to in Article 1 is regulated, nationals ofMember States who fulfil the conditions of professional qualificationlaid down in Articles 2, 5 and 6 shall be entitled to the professionaltitle of the host Member State which in that State corresponds to thoseconditions, and shall use the abbreviation thereof.
Article 15
1. Member States shall take the necessary measures to enable the
persons concerned to obtain information on the health and socialsecurity laws and, where applicable, on the professional ethics of thehost Member State.
For this purpose, Member States may set up information centres from
which such persons may obtain the necessary information. The host
Member States may require the persons concerned to contact thesecentres.
2. Member States may set up the centres referred to in paragraph 1
under the aegis of the competent authorities and bodies which theyshall designate within the period laid down in Article 19 (1).
3. Member States shall see to it that, where appropriate, the persons
concerned acquire, in their own interest and in that of their customers,the linguistic knowledge necessary for the practice of their professionin the host Member State.
CHAPTER VI
Finalprovisions
Article 16
In the event of justified doubts, the host Member State may require of
the competent authorities of another Member State confirmation of theauthenticity of the diplomas, certificates and other formal qualificationsissued in that other Member State and referred to in Chapters II and III,
and also confirmation of the fact that the person concerned has fulfilled
all the training requirements laid down in Directive 85/432/EEC.
Article 17
Within the time limit laid down inArticle 19 (1), Member States shall
designate the authorities and bodies competent to issue or receive thediplomas, certificates and other formal qualifications as well as thedocuments and information referred to in this Directive and shall forth-
with inform the other Member States and the Commission thereof.
Article 18
This Directive shall also apply to nationals of Member States who, in
accordance withRegulation (EEC) No 1612/68, are pursuing or willpursue as employed persons one of the activities referred to in Article1.
Article 19
1. Member States shall bring into force the measures necessary to
comply with this Directive before 1 October 1987. They shall forthwithinform the Commission thereof.
2. Member States shall communicate to the Commission the texts of
the main provisions of national law which they adopt in the fieldcovered by this Directive.1985L0433 — EN — 01.01.1995 — 003.001 — 9
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Article 20
Where a Member State encounters major difficulties in certain fields
when applying this Directive, the Commission shall examine these
difficulties in conjunction with that State and shall request the opinion
of the Pharmaceutical Committee set up under Decision 75/320/EEC(
1).
Where necessary, the Commission shall submit appropriate proposals to
the Council.
Article 21
This Directive is addressed to the Member States.1985L0433 — EN — 01.01.1995 — 003.001 — 10
(1) OJ No L 147, 9. 6. 1975, p. 23.