1985L0433 — EN — 31.07.2001 — 004.001 — 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
►M3Directive 2001/19/EC of the European Parliament and of the Council of
14 May 2001L 206 1 31.7.2001
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
▼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 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 with regard to establishment and provision of services isprohibited as from the end of the transitional period; whereas the 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-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
giveninthe Member States, it is n ecessary to lay downcertaincoordi-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 actioninrespect of certainactivities inthe field of pharmacy(
4);
Whereas incertainMember States access to certainactivities inthe
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 inan other Member State;
Whereas, under their national policies in the sphere of public health,
which seek inter 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 — 31.07.2001 — 004.001 — 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.
▼B
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 possessionof 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, inadditionto 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,
regulationor admin istrative actioninthe Member States which prohibit
companies from practising certain activities or impose on them certain
conditions for such 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 drawnbetweenthe requiremen ts to be satisfied onfirsttaking 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 downn o
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 inthe Member States to possessionof a diploma,
certificate or other evidence of formal qualification in pharmacy are
pursued by both employed and self-employed persons, or by the sameperson s inboth capacities inthe course of their profession al 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 ►
M3referred
to in the Annex ◄.1985L0433 — EN — 31.07.2001 — 004.001 — 3
(1) OJ No L 257, 19. 10. 1968, p. 2.
▼B
CHAPTER II
Diplomas,certificatesandotherevidenceofformalqualificationsin
pharmacy
Article 2
1. Each Member State shall recognize the diplomas, certificates and
other formal qualifications listed in ►M3the Annex ◄awarded to
nationals of Member States by other Member States in accordancewith Article 2 of Directive 85/432/EEC by giving such qualifications,as regards the right of access to and pursuit of the activities referredto inArticle 1, the same effect inits territory as those diplomas, certi-
ficates and other formal qualifications, listed in ►
M3the Annex ◄,
which it itself awards.
2. However, Member States need not give effect to the diplomas,
certificates and other formal certificates referred 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 havebeeninoperationfor less thanthree years shall also be regarded asnew.
Five years after the date stipulated inArticle 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 5
Where, ina Member State, access to or pursuit of on e of the activities
referred to in Article 1 is subject not only to the possession of adiploma, certificate or other formal qualification mentioned in►
M3the Annex ◄but also to the requirement of additional profes-
sional experience, that State shall accept as sufficient evidence in thisrespect a certificate issued by the competent authorities of the person's
Member State of originor of the Member State from which he comes,
attesting that he has pursued the said activities for an equivalent periodinhis Member State of originor inthe Member State from which hecomes.
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 ofMember 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 requirements
if:
— 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 each case, if:
— they are accompanied by a certificate stating that their holders have
been effectively and lawfully engaged in one of the activities1985L0433 — EN — 31.07.2001 — 004.001 — 4
▼M3
▼B
▼B
referred to inArticle 1 (2) of Directive 85/432/EEC ina Member
State for at least three consecutive years during the five yearspreceding the award of the certificate, provided that this activity is
regulated inthat 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 ►
M3the Annex ◄shall
be treated, for the purposes of the Directive, as the diplomas set out
inthat                             iftheyareaccompaniedbyacertificatestating
that they attesttotrainingconformingtotheprovisionsofDirective85/432/EEC referredtoi
nArticle2ofthisDirectiveandshallbetreatedby
the MemberStateswhichawardedthemasthosedesignationsareset
out in►M3theAnnex◄ofthisDirective.
Article 6a
Diplomas, certificates and other university or equivalent qualifications
in pharmacy which attest to training received by nationals of the
Member States onthe territory of the former GermanDemocraticRepublic 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 as
the qualifications awarded by the competent German authoritiesand referred to in ►
M3the Annex ◄,a nd
— they are accompanied by a certificate stating that their holders have
effectively and lawfully been engaged in Germany in one of the
activities referred to inArticle 1 (2) of Directive 85/432/EEC for
at least three consecutive years during the five years prior to thedate of issue of the certificate, provided that such activity is regu-lated inthe Member State inquestion .
CHAPTER IV
Useofacademic title
Article 7
1. Without prejudice to Article 14, host Member States shall ensurethat 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 abbreviationthereof, of their Member State oforiginor of the Member State from which they come, inthe lan guage
of that State. Host Member States may require this title to be followed
by the name and location of the establishment or examining boardwhich awarded it.
2. If the academic title used inthe Member State of origin , or inthe
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 personto use the title employed inthe Member State of originor the Member State from which he comesin suitable wording to be indicated by the host Member State.1985L0433 — EN — 31.07.2001 — 004.001 — 5
▼M2
▼BM3Annex◄►
▼B
CHAPTERV
Provisionstofacilitatetheeffectiveexerciseoftherightofestab-
lishment
Article8
1.AhostMemberStatewhichrequiresofitsnationalsproofof
goodcharacterorgoodreputewhentheytakeupforthefirsttime
anyoftheactivitiesreferredtoinArticle1shallacceptassufficientevidence,inrespectofnationalsofotherMemberStates,acertificateissuedbyacompetentauthorityintheMemberStateoforiginorintheMemberStatefromwhichtheforeignnationalcomes,attestingthattherequirementsoftheMemberStateastogoodcharacteror
goodreputefortakinguptheactivityinquestionhavebeenmet.
2.WheretheMemberStateoforiginortheMemberStatefrom
whichtheforeignnationalcomesdoesnotrequireproofofgoodchar-acterorgoodreputeofpersonswishingtotakeuptheactivityin
questionforthefirsttime,thehostMemberStatemayrequireof
nationalsoftheMemberStateoforiginoroftheMemberStatefromwhichtheforeignnationalcomesanextractfromthejudicialrecordor,failingthis,anequivalentdocumentissuedbyacompetentauthorityintheMemberStateoforiginortheMemberStatefromwhichtheforeignnationalcomes.
3.IfthehostMemberStatehasdetailedknowledgeofaserious
matterwhich,priortotheestablishmentinthatStateofthepersoninquestion,hasoccurredoutsideitsterritoryandislikelytoaffectthetakingupwithinitsterritoryoftheactivityconcerned,itmayinform
theMemberStateoforiginortheMemberStatefromwhichthe
foreignnationalcomes.
TheMemberStateoforiginortheMemberStatefromwhichthe
foreignnationalcomesshallverifytheaccuracyofthefactsifthey
arelikelytoaffectthetakingupoftheactivityinquestioninthat
MemberState.TheauthoritiesinthatStateshalldecideonthenature
andextentoftheinvestigationstobemadeandshallinformthehost
MemberStateofanyconsequentialactionwhichtheytakewithregard
tothecertificatesordocumentstheyhaveissued.
4.MemberStatesshallensuretheconfidentialityoftheinformation
whichisforwarded.
Article9
1.Where,inahostMemberState,provisionslaiddownbylaw,regulationoradminsitrativeactionareinforcelayingdownrequire-
mentsastogoodcharacterorgoodrepute,includingprovisionsfor
disciplinaryactioninrespectofseriousprofessionalmisconductor
convictionforcriminaloffencesandrelatingtothepursuitofanyof
theactivitiesreferredtoinArticle1,theMemberStateoforiginortheMemberStatefromwhichtheforeignnationalcomesshallforward
tothehostMemberStateallnecessaryinformationregardingmeasures
ordisciplinaryactionofaprofessionaloradministrativenaturetakenin
respectofthepersonconcerned,orcriminalpenaltiesimposedonhim
whenpursuinghisprofessionintheMemberStateoforiginorinthe
MemberStatefromwhichhecame.
2.IfthehostMemberStatehasdetailedknowledgeofaserious
matterwhich,priortotheestablishmentinthatStateofthepersonin
question,hasoccurredoutsideitsterritoryandislikelytoaffectthe
pursuitwithinitsterritoryoftheactivityconcerned,itmayinformtheMemberStateoforiginortheMemberStatefromwhichtheforeignnationalcomes.
TheMemberStateoforiginortheMemberStat
efromwhichthe foreign
nationalcomesshallverifytheaccuracyofth efactsiftheyarelikely
toaffectinthatMemberStatethepursuitofth eactivityinquestion.The
authoritiesinthatStateshalldecideonth enatureandextentofthe
investigationstobemadeandshallinfor mthehostMemberStateof
anyconsequentialactionwhichtheytake withregardtotheinformation
theyhaveforwardedinaccordance withparagraph1.1985L0433 — EN — 31.07.2001 — 004.001 — 6
▼B
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 the
Member State of originor inthe Member State from which the foreign
national comes.
Where the Member State of originor the Member State from which the
foreign national comes does not impose any requirements of this natureon 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 certificates
issued inthe host Member State.
Article 11
The documents referred to in Articles 8, 9 and 10 may not be presented
more thanthree mon ths 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, 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 delays resulting from any appeal that may be
made uponthe completionof this procedure.
2. Inthe cases referred to inArticles 8 (3) an d 9 (2), a request for
re-examination shall suspend the period stipulated in paragraph l.
Whencon sulted, the Member State of originor the Member State from
which the foreign national comes shall give its reply within threemonths.
Onreceipt of the reply or at the en d 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 solemndeclarationan d where the form of such oath ordeclaration cannot be used by nationals of other Member States, thatMember State shall ensure that an appropriate and equivalent form ofoath or declaration is offered to the 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 qualification
laid down in Articles 2, 5 and 6 shall be entitled to the professional
title of the host Member State which inthat State correspon ds 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 thehost Member State.
For this purpose, Member States may set up information centres from
which such persons may obtain the necessary information. The hostMember States may require the persons concerned to contact thesecentres.1985L0433 — EN — 31.07.2001 — 004.001 — 7
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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 professioninthe host Member State.
CHAPTER VI
Finalprovisions
Article 16
Inthe even t 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 inthat other Member State an d referred to inChapters II an d 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
Withinthe time limit laid downin Article 19 (1), Member States shall
designate the authorities and bodies competent to issue or receive the
diplomas, certificates and other formal qualifications as well as the
documents 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 with Regulation (EEC) No 1612/68, are pursuing or willpursue as employed persons one of the activities referred to in Article1.
Article 18a
Member States shall notify the Commission of the laws, regulations or
administrative provisions they adopt as regards the award of diplomas,certificates and other evidence of formal qualifications in the field
covered by this Directive. The Commissionshall publish anappropriate
notice in the Official Journal of the European Communities , listing the
names adopted by the Member States for the training qualificationsconcerned and, where applicable, for the corresponding professionaltitle.
Article 18b
Each Member State shall recognise as sufficient proof, in respect of
nationals of Member States whose diplomas, certificates and otherevidence of formal qualifications in the field covered by this Directive
do not correspond to the names listed for that Member State in this
Directive, the diplomas, certificates and other evidence of formal quali-fications awarded by those Member States and accompanied by acertificate issued by the competent authorities or bodies. The certificateshall state that the diplomas, certificates and other evidence of formalqualifications in question have been awarded on completion of educa-
tion and training that complies with the provisions of this Directive and
are treated by the awarding Member State as equivalent to those whosenames are listed therein.
Article 18c
Member States shall examine diplomas, certificates and other evidence
of formal qualifications in the field covered by this Directive obtainedby the holder outside the EuropeanUn ionincases where thosediplomas, certificates and other evidence of formal qualifications havebeen recognised in a Member State, as well as of training undergone1985L0433 — EN — 31.07.2001 — 004.001 — 8
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▼M3
and/or professional experience gained in a Member State. The Member
State shall give its decisionwithinthree mon ths of the date onwhichthe applicant submits his application together with full supporting
documentation.
Article 18d
Where the applicationis rejected, Member States shall duly give the
reasons for decisions on applications for recognition of diplomas, certi-ficates and other evidence of formal qualifications in the field coveredby this Directive.
Applicants shall have a right of appeal before the courts under national
law. That right of appeal shall likewise apply inthe even t of failure toreach a decisionwithinthe stipulated period.
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.
Article 20
Where a Member State encounters major difficulties in certain fields
when applying this Directive, the Commission shall examine thesedifficulties 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 — 31.07.2001 — 004.001 — 9
(1) OJ No L 147, 9. 6. 1975, p. 23.▼B
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ANNEX
Titlesofdiplomas,certificates andotherevidence offormalqualificationsinpharmacy
Country Title of qualification Awarding body
Belgique/
België/Belgien— Diploma vanapotheker
— Diplôme de pharmacien1. De universiteiten / les universités
2. De bevoegde Examencommissie van
de Vlaamse Gemeenschap / le Jury
compétent d'enseignement de la
Communauté française
Danmark Bevis for bestået farmaceutisk kandi-
dateksamenDanmarks Farmaceutiske Højskole
Deutschland Zeugnis über die Staatliche Pharma-
zeutische PrüfungZuständige Behörden
Ελλάς Άδεια άσκησης φαρµακευτικού
επαγγέλµατοςΝοµαρχιακή Αυτοδιοίκηση
España Título de licenciado en farmacia Ministerio de Educación y Cultura / El
rector de una Universidad
France Diplôme d'Etat de pharmacien/
Diplôme d'Etat de docteur enphar-
macieUniversités
Ireland Certificate of Registered Pharmaceu-
tical Chemist
Italia Diploma o certificato di abilitazione
all'esercizio della professione di farm-
acista ottenuto in seguito ad un esame
di StatoUniversità
Luxembourg Diplôme d'Etat de pharmacienJury d'examen d'Etat + visa du min istre
de l'éducation nationale
Nederland Getuigschrift van met goed gevolg
afgelegd apothekersexamenFaculteit Farmacie
Österreich Staatliches Apothekerdiplom Bundesministerium für Arbeit, Gesund-
heit und Soziales
Portugal Carta de curso de licenciatura em
Ciências FarmacêuticasUniversidades
Suomi/Finland Proviisorin tutkinto / provisorexamen 1. Helsingin yliopisto / Helsingfors
universitet
2. Kuopionyliopisto
Sverige ApotekarexamenUppsala un iversitet
United
KingdomCertificate of Registered Pharmaceu-
tical Chemist1985L0433 — EN — 31.07.2001 — 004.001 — 10