1985L0433 — EN — 01.01.1986 — 001.001 — 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
▼B
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 Articles49 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 with regard to establishment and provision of services isprohibited asfrom the end of the trans itional period; whereasthe prin-ciple of such treatment based on nationality applies, in particular, to the
grant of any authorization required for the practice of certain activities,
and also to registration with or membership of professional organiza-tionsor 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
Statesare required not to grant any form of aid likely to dis tort theconditions of establishment;
WhereasArticle 57 (1) of the Treaty providesthat Directivesbe
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);
Whereasin certain Member Statesacces sto certain activitiesin 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 viewsamong the Member Stateson thispoint, 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 effectsof the recognition of diplomas ,certificatesand other evidence of formal qualificationsin pharmacy1985L0433 — EN — 01.01.1986 — 001.001 — 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 thisOfficial 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 thisDirective mus t provide a certificate from thecompetent authoritiesof hiscountry of origin or of the country fromwhich he comes stating that these certificates of training are thosecovered by the Directive;
WhereasthisDirective doesnot affect the provis ionslaid down by law,
regulation or administrative action in the Member States which prohibit
companies from practising certain activities or impose on them certain
conditionsfor s uch practice;
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 such rules for the 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 workerswithin the Community(
1) laysdown 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 both employed and self-employed persons, or by the 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,certificatesor other formal qualificationsin pharmacy referred to inArticle 4.1985L0433 — EN — 01.01.1986 — 001.001 — 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 qualificationslis ted in Article 4 awarded to nationalsofMember Statesby other Member Statesin accordance with Article 2
of Directive 85/432/EEC by giving such qualifications, as regards the
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 Statesneed not give effect to the diplomas ,
certificatesand other formal certificatesreferred to in paragraph 1
with 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 effectsof mutual recognition of the diplomas ,
certificatesand other formal certificatesreferred 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 aslaid down in Article 2 to the diplomas ,certificatesand other formal qualificationsawarded by other Member-States except in the case of the pursuit as an employed person in accor-
dance with Regulation (EEC) No 1612/68 of the activitiesreferred to
in Article 1.
Aslong asthe Hellenic Republic makesus e of thisderogation and
without prejudice to Article 45 of the 1979 Act of Accession, the otherMember Statess hall not be required to give effect asprovided for inArticle 2 to the certificatesreferred 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 activitiesreferred 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 theeffectsof mutual recognition of diplomas , certificatesand other formalqualificationswith a view to facilitating the effective exercis e of theright of establishment between the Hellenic Republic and the other
Member States. The Council shall act on these proposals in accordance
with 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:
Lediplômelégal depharmacien/het wettelijk diplomavanapoteker
(the legal diploma in pharmacy) awarded by the facultiesof medi-cine and pharmacy of the Universities, by the Central examining
board or by the State examining boardsfor univers ity education;
(b)in Denmark:
Bevis for bestået farmaceutisk kandidateksamen (the university
pharmacy certificate);1985L0433 — EN — 01.01.1986 — 001.001 — 4
▼B
(c)in the Federal Republic of Germany:
(1)Zeugnisüberdiestaatliche PharmazeutischePrüfung (the State
examination certificate in pharmacy) awarded by the competentauthorities;
(2) Certificatesfrom the competent authoritiesthe Federal
Republic of Germany stating that the diplomas awarded after8 May 1945 by the competent authoritiesof the German Demo-cratic Republic are recognized asequivalent to thos e referred to
in point 1 above;
(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).
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 Article
4 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 oforigin or of the Member State from which he comes, attesting that hehas pursued the said activities for an equivalent period in his Member
State 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.1985L0433 — EN — 01.01.1986 — 001.001 — 5
▼M1
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▼B
CHAPTER III
Establishedrights
Article 6
Diplomas, certificates and other university or equivalent qualifications
in pharmacy which were awarded to nationalsof Member StatesbyMember States and which do not satisfy all the minimum trainingrequirementslaid down in Article 2 of Directive 85/432/EEC s hall betreated as diplomas satisfying these requirements if:
— they are evidence of training which wascompleted before the
implementation of the said Directive, or
— they are evidence of training which wascompleted after but which
wascommenced before the implementation of the s aid Directive,
and, in each case, if:
— they are accompanied by a certificate stating that their holders have
been effectively and lawfully engaged in one of the activitiesreferred to in Article 1 (2) of Directive 85/432/EEC in a MemberState for at least three consecutive years during the five years
preceding the award of the certificate, provided that thisactivity is
regulated in that State.
CHAPTER IV
Useofacademic title
Article 7
1. Without prejudice to Article 14, host Member States shall ensure
that nationalsof Member Stateswho fulfil the conditionslaid down in
Articles2, 5 and 6 have the right to us e the lawful academic title and,
where appropriate, the abbreviation thereof, of their Member State oforigin 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 board
which 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 in
the host Member State with a title requiring in that State additionaltraining which the person concerned has not undergone, the hostMember State may require such a person to use the title employed inthe 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 time
any of the activities referred to in Article 1 shall accept as sufficient
evidence, in respect of nationals of other Member States, a certificateissued by a competent authority in the Member State of origin or inthe Member State from which the foreign national comes, attestingthat the requirementsof the Member State asto 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 comesdoesnot 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 ofnationalsof the Member State of origin or of the Member State fromwhich the foreign national comesan extract from the judicial record or,failing this, an equivalent document issued by a competent authority in1985L0433 — EN — 01.01.1986 — 001.001 — 6
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the Member State of origin or the Member State from which the
foreign 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 inquestion, has occurred outside its territory and is likely to affect the
taking up within itsterritory of the activity concerned, it may inform
the 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 comess hall verify the accuracyof the factsif they are likely to affect the taking up of the activity in
question in that Member State. The authorities in that State shall decide
on 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 isforwarded.
Article 9
1. Where, in a host Member State, provisions laid down by law,
regulation or adminsitrative action are in force laying down require-
mentsasto good character or good repute, including provis ionsfor
disciplinary action in respect of serious professional misconduct orconviction for criminal offencesand relating to the purs uit of any ofthe activitiesreferred to in Article 1, the Member State of origin orthe Member State from which the foreign national comess hall forward
to the host Member State all necessary information regarding measures
or disciplinary action of a professional or administrative nature taken inrespect 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 comess hall verify the accuracy of thefactsif they are likely to affect in that Member State the purs uit 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 accordancewith paragraph 1.
3. Member States shall ensure the confidentiality of the information
which isforwarded.
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 foreignnational comes.
Where the Member State of origin or the Member State from which the
foreign national comesdoesnot impos e any requirementsof thisnatureon those wishing to take up or pursue the activity in question, the host
Member State shall accept from such nationals a certificate issued by a
competent authority in that State corresponding to the certificatesissued in the host Member State.
Article 11
The documentsreferred to in Articles8, 9 and 10 may not be pres ented
more than three months after their date of issue.1985L0433 — EN — 01.01.1986 — 001.001 — 7
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Article 12
1. The procedure for authorizing the person concerned to take up
any of the activitiesreferred to in Article 1, purs uant to Articles8, 9and 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 delaysres ulting from any appeal that may be
made upon the completion of thisprocedure.
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 comess hall give itsreply 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 oath
or make a solemn declaration and where the form of such oath or
declaration cannot be used by nationals of other Member States, thatMember State shall ensure that an appropriate and equivalent form ofoath or declaration isoffered to the pers onsconcerned.
Article 14
Where in a host Member State, the use of the professional title relating
to one of the activitiesreferred to in Article 1 isregulated, nationalsof
Member States who fulfil the conditions of professional qualification
laid 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 social
security laws and, where applicable, on the professional ethics of the
host 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 Statesmay s et up the centresreferred to in paragraph 1
under the aegisof the competent authoritiesand bodieswhich 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 authoritiesof 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 fulfilledall the training requirementslaid down in Directive 85/432/EEC.1985L0433 — EN — 01.01.1986 — 001.001 — 8
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Article 17
Within the time limit laid down inArticle 19 (1), Member Statess hall
designate the authorities and bodies competent to issue or receive the
diplomas, certificates and other formal qualifications as well as the
documentsand information referred to in thisDirective and s hall forth-with inform the other Member Statesand the Commis s ion thereof.
Article 18
This Directive shall also apply to nationals of Member States who, in
accordance with Regulation (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 thisDirective before 1 October 1987. They s hall forthwith
inform 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 thisDirective.
Article 20
Where a Member State encountersmajor difficultiesin certain fields
when applying this Directive, the Commission shall examine thesedifficulties in conjunction with that State and shall request the opinionof 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 — 01.01.1986 — 001.001 — 9
(1) OJ No L 147, 9. 6. 1975, p. 23.