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Amendment Of The Pharmacy Act And The Pharmacist Chamber Act 2001

Original Language Title: Änderung des Apothekengesetzes und des Apothekerkammergesetzes 2001

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75. Federal Act, with which the Pharmacy Act and the Pharmacerkammergesetz 2001 will be amended

The National Council has decided:

Article 1

Amendment of the pharmacy law

The law of 18 December 1906, concerning the regulation of pharmacy (pharmacy law), RGBl. No. 5/1907, as last amended by the Federal Act BGBl. I n ° 90/2006 and the Federal Ministries of State Law 2007, BGBl. I n ° 6, shall be amended as follows:

1. § 3 (1) Z 2 reads:

" 2.

the general professional qualification as a pharmacist according to § 3b or a vocational training recognized in accordance with § 3c, "

2. § 3 (1) Z 7 reads:

" 7.

the knowledge of the German language required for the management of a pharmacy. "

3. § 3 (5) reads:

"(5) As proof in accordance with paragraph 1 (1) (2), persons according to § 62b (1) shall be entitled to bear witness to the filing of the examination for the profession of pharmacist."

4. § § 3a to 3c together with headings:

" State Pharmacy Diploma

§ 3a. (1) Persons who have obtained the academic degree of a magister of pharmacy at an Austrian university or whose foreign study degree is equivalent to that of an Austrian university in accordance with the national degree. has been nostrified and wants to obtain the general entitlement to practise the profession, have to complete a one-year professional training in a public pharmacy or anstaltsapotheke, and have the examination for the pharmacy profession before the Audit Commission of the Austrian Pharmacists ' Chamber successfully ,

(2) At the end of the training provided for in paragraph 1, the Austrian Pharmacists ' Chamber shall, by means of the State Secretariat at which the examination for the pharmacy profession has been filed, have the State Pharmacist's Diploma.

General professional authority

§ 3b. (1) A general professional qualification is required for the exercise of the profession of pharmacist in Austria. The general professional authority shall be given if:

1.

the State Pharmacist Diploma pursuant to § 3a or a training certificate in accordance with § 3c,

2.

the reliability and

3.

the knowledge of the German language required for the exercise of the pharmacist's profession

exist.

(2) It shall not be reliable within the meaning of paragraph 1 (2), who shall, in particular:

1.

has been sentenced to more than one year in prison for one or more offences committed with intent, as long as the conviction is not satisfied, and in accordance with the peculiative nature of the offence committed or after the offence has been committed; the person who has been convicted of the possible commission of a similar or similar criminal offence for the exercise of the profession of pharmacist is not appropriate; or

2.

may not exercise the profession of pharmacist on the basis of an official or professional ban.

(3) The existence of the conditions set out in paragraph 1 of this article must be proven by the Austrian Pharmacists ' Chamber prior to the commence of their professional activities and submitting the necessary documents.

(4) When the conditions for the granting of the general professional authorization pursuant to paragraph 1 are fulfilled, the Austrian Chamber of Pharmacists shall have no delay within a period of three months from the date on which the application, together with the , it has been submitted in full to provide the general professional authority for the exercise of the profession. If these conditions are not met, the general right to practise the profession shall be subject to a period of three months.

Recognition of qualifications

§ 3c. (1) On applications for recognition of diplomas, certificates and other evidence of formal qualifications (evidence of formal qualifications), the other Contracting Parties to the EEA Agreement or the Swiss Confederation for the purposes of the profession of pharmacist , the Austrian Chamber of Pharmacists shall decide on the basis of the following provisions.

(2) The Austrian Chamber of Pharmacists shall recognise the evidence of formal qualifications referred to in Annex V, point 5.6.2. of Directive 2005 /36/EC, which satisfies the minimum training requirements laid down in Article 44 of Directive 2005 /36/EC, if the Evidence of formal qualifications shall be issued by the competent authorities of the Member States and, if necessary, accompanied by the certificates referred to in Annex V, point 5.6.2. of Directive 2005 /36/EC.

(3) The Austrian Chamber of Pharmacists shall recognise evidence of formal qualifications satisfying the minimum training requirements laid down in Article 44 of Directive 2005 /36/EC if the evidence of formal qualifications is not in accordance with the requirements of Annex V, point 5.6.2. of the Directive 2005 /36/EC, but is accompanied by a certificate issued by the competent authorities or bodies, according to which, or otherwise it is established that these evidence of formal qualifications are to be completed by a Training under Article 44 of Directive 2005 /36/EC, and therefore Annex V, Point 5.6.2. of Directive 2005 /36/EC is equivalent to that provided for in Directive 2005 /36/EC.

(4) The Austrian Chamber of Pharmacists has to recognise evidence of formal qualifications which does not satisfy all the requirements of Article 44 of Directive 2005 /36/EC, provided that:

1.

proof of the completion of a training which has been started before the dates set out in Annex V, point 5.6.2. of Directive 2005 /36/EC, or which have the same legal validity in the Member State concerned, such as those of evidence of formal qualifications awarded to him and

2.

is accompanied by a certificate stating that the holder has been in full service as a pharmacist for at least three years before the date of issue of the certificate for at least three years and has been legally in full service. Periods completed in part-service shall be taken into account in this respect with their proportionate share.

(5) In the event that the applicant does not fill in full the requirements of the professional practice referred to in paragraph 4 (2), the Austrian Chamber of Pharmacists may recognise the evidence of formal qualifications of an applicant by reason of his/her previous work. It shall, in particular, take account of the duration and nature of the activity carried out in a pharmacy and any interruptions to that activity, and shall ensure that the activity demonstrated in the nature and scope of the activity in question is carried out in the Full service in accordance with paragraph 3 as far as possible.

(6) Training evidence issued by a third country to nationals of Contracting Parties to the EEA Agreement or of the Swiss Confederation shall be treated as evidence of formal qualifications within the meaning of paragraph 1, provided that the holder of the Evidence of three years of professional experience in full service as a pharmacist in the Member State which first recognised the third country training and that that Member State has a full service equivalent to that Professional experience attested.

(7) In the case of applications as referred to in paragraph 5, a compensatory measure may be required either for a one-year practical training in a public pharmacy or a hospital pharmacy according to § 3a or the filing of the examination for the pharmacy profession in accordance with § 3a. to choose from. The duration and nature of the applicant ' s activities shall be taken into account in the case of the advance of a compensatory measure, as well as the extent to which pharmacists ' activities have been carried out on their own account and the period of time of return shall be taken into account. of the last activity as a pharmacist. The rewriting of a compensatory measure shall be omitted if the recognition advertiser has the minimum necessary qualifications or compensatory measures taken on the basis of a common platform adopted in accordance with Article 15 in conjunction with Article 58 of Directive 2005 /36/EC can be established.

(8) The Austrian Chamber of Pharmacists has to confirm the entry of an application in accordance with paragraph 1 within one month and, if necessary, to issue a request for improvement.

(9) The Austrian Chamber of Pharmacists shall decide on the recognition of evidence of formal qualifications in accordance with paragraphs 2 to 6 within three months from the date on which the application and all documents have been submitted.

(10) In so far as the conditions for the recognition of qualifications as provided for in paragraphs 2 to 9 are met and the applicant also requests, in the application for the recognition of his qualifications, the granting of the general right to be granted, he shall be entitled to: in the event of the further conditions laid down in section 3b, the same shall be granted simultaneously with the recognition.

(11) Third-country nationals who

1.

on a residence permit entitled "Permanent residence-EC" according to § 45, "Permanent residence-family member" in accordance with § 48 or "Permanent stay-EC" of another Member State in accordance with § 49 Niederlassungs-und Residence Act (NAG), BGBl. I No 100/2005, or

2.

the holder of a permanent residence card pursuant to section 54 of the NAG,

, nationals of an EEA Contracting State or of the Swiss Confederation shall be treated in the same way as regards the application of Directive 2005 /36/EC.

(12) The Austrian Chamber of Pharmacists has, at the request of the competent authority of a requesting State Party to the Agreement on the European Economic Area (EEA States Parties) and the Swiss Confederation, in the course of a request to the Austrian Pharmacists ' Chamber Diplomanrecognition procedure The data required for the recognition of diplomas by the recognition agent (training and aptitude tests). "

5. According to § 3c, the following § § 3d to 3f shall be inserted together with the headings:

" Withdrawal and erasal of the general professional qualification

§ 3d. (1) The general professional authorization of a pharmacist shall be recognized by the Austrian Chamber of Pharmacists, if it is found that the existence of the reliability or an essential condition for recognition of a Evidence of formal qualifications in the assessment of the general right to work has been wrongly assessed as being fulfilled.

(2) The general professional authorization of a pharmacist shall be issued if a prohibition of professional practice is issued in accordance with Section 41 (1) (6) of the Pharmacists ' Act 2001 in a disciplinary recognition.

(3) In the case of the superstipation of the general professional authorization pursuant to paragraph 1, a request for a new grant may be submitted at the earliest after the expiry of six months after the legal force of the appellant in accordance with paragraph 1.

(4) In the event of the general professional authorization being extinguishing in accordance with paragraph 2, a request for a new grant may be submitted at the earliest three months before the expiry of the time limit for which the applicant has been prohibited from exercising his profession.

Pharmacy ID

§ 3e. (1) Pharmacists who have obtained the general right to work and who are active in an Austrian pharmacy have to apply to the Austrian Pharmacists ' Chamber to issue a professional card (a pharmacist's card).

(2) More information on the form and functionalities of the pharmacy card, in particular on the possibility of a qualified electronic signature, the issuing and issuing of the pharmacist's certificate, the obligations of the Pharmacists 'holders and the issuing authority, as well as the cost-covering fee design, determine guidelines to be adopted by the delegates' meeting of the Austrian Pharmacists ' Chamber.

Professional title

§ 3f. (1) The professional title "pharmacist" or "pharmacist" may only be given by pharmacists (§ § 3a and 3b).

(2) Any name or title which is appropriate to pretend the right to exercise the profession of pharmacist, membership of that profession or the existence of a pharmacy within the meaning of this Federal Law shall be prohibited. "

6. § 5 and headline is:

" Training, examination and activities of pharmacists

§ 5. The Federal Minister of Health, Family and Youth has the training, the use during the training and the examination for the pharmacy profession (§ 3a (1)), the activities reserved for pharmacists in pharmacies as well as more detailed provisions on to regulate the period of service required for the receipt of the authorization to operate a public pharmacy or the time of service required for regaining it (Section 3 (6)) following the hearing of the Austrian Pharmacists ' Chamber by Regulation. Pharmacists ' activities in pharmacies reserved for pharmacists are, in particular, the development, manufacture and testing of medicinal products, the supply of medicinal products reserved for pharmacies, and the advisory and/or Information activities on medicinal products and the review of medical supplies in hospitals. "

7. In § 8 (3) and (5), the word shall be "justifiable" through the phrase "generally professional" and in § 24 (3) the word "defendants" through the phrase "generally occupational" replaced.

8. In § 45, the first paragraph receives the sales designation "(1)" . (2) to (4) read:

" (2) An appeal to the independent administrative Senate of the country may be brought against the authority of the district administrative authority.

(3) In the case of the Austrian Pharmacists ' Chamber pursuant to § § 3b, 3c and 3d, an appeal may be made to the independent administrative Senate of the country in whose area the applicant has its main residence. If the applicant does not have a main residence in the country, an appeal can be made to the Independent Administrative Senate of the country in whose area the main residence or habitual residence held last in Austria is situated is. If such a failure has passed, an appeal may be made to the Independent Administrative Senate of the country in whose field the profession of the pharmacist is to be pursued.

(4) An appeal to the Federal Minister for Health, Family and Youth may be brought against the defamation of the Governor of the State and against any other code of the Austrian Pharmacists ' Chamber. "

9. In accordance with § 45, the following § 45a and heading is inserted:

" Exemption of fees

§ 45a. The charges, pleadings and incumbous acts resulting from this Federal Act are exempted from the charges and administrative duties of the Federal Government, insofar as they fall within the competence of the Austrian Pharmacists ' Chamber. "

§ 54 reads:

" § 54. The district administrative authority shall decide on applications for the approval of the transfer of a public pharmacy in accordance with Section 14 (2) to another location. Prior to the decision, the Austrian Pharmacists ' Chamber and the locally competent medical chamber shall be heard. "

11. In accordance with Section 62a (5), the following paragraph 6 is added:

" (6) At the date of entry into force of the pharmacy law novella BGBl. I n ° 75/2008, the legal situation before the entry into force of this Federal Act should continue to be applied. "

12. In accordance with § 62a the following § 62b is inserted:

" § 62b. (1) For pharmacists who have obtained the academic degree of a magister of pharmacy at an Austrian university or whose foreign study degree is from an Austrian university than the national degree has been notified accordingly, and the examination for the pharmacy profession before the 1. In January 1994, the general professional authority is granted, provided that there is no offence which, in accordance with § 3d, leads to a disqualification or to the erasable of the general professional qualification.

(2) Pharmacists, who are at the time of the entry into force of § 3a in the version of the Federal Law BGBl. I n ° 75/2008 are legally authorised to act as a pharmacist or pharmacist, without the need for an additional general professional authorization, to act as a pharmacist. "

13. In accordance with § 67, the following § 67a and heading is inserted:

" Implementation of Community law

§ 67a. Through this federal law,

1.

Directive 2005 /36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications, OJ L 139, 30.4.2005, p. No. 22, as last amended by Council Directive 2006 /100/EC of 20 November 2006 on the adaptation of certain directives in the field of free movement of persons to take account of the accession of Bulgaria and Romania, OJ L 255, 30.9.2006, p. No. OJ L 363, 20 December 2006, p. 141;

2.

the Agreement between the European Community and its Member States, of the one part, and the Swiss Confederation, of the other part, on the free movement of persons, OJ No. OJ L 114/6 of 30 April 2002, BGBl. III. No 133/2002, as amended by the Protocol, with a view to the accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia as a result of their accession to the European Union, 1. No. OJ L 89/30 of 28 March 2006, BGBl. III No 162/2006;

3.

Council Directive 2003 /109/EC of 25 November 2003 on the legal status of third-country nationals who are long-term residents, OJ L 327, 31.12.2003, p. No. OJ No L 16, 23. Jänner 2004, p. 44;

4.

Directive 2004 /38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States, amending the Regulation (EEC) No 1612/68 and repealing Directives 64 /221/EEC, 68 /360/EEC, 72 /194/EEC, 73 /148/EEC, 75 /34/EEC, 75 /35/EEC, 90 /364/EEC and 93 /96/EEC, OJ L 206, 22.7.1992, p. No. OJ L 158, 30.4.2004, p.77, as amended, OJ L 327, 28.04.2004, p. No. OJ L 229, 29 June 2004, p. 35;

to be transposed into Austrian law. "

Article 2

Amendment of the Pharmacerkammergesetz 2001

The Federal Act on the Austrian Pharmacists ' Chamber (Pharmacerkammergesetz 2001), BGBl. I n ° 111/2001, as last amended by the Federal Law BGBl. I n ° 112/2007, is amended as follows:

1. § 2 para. 3 Z 4 reads:

" 4.

the issue of certificates referred to in Article 50 (1) of Directive 2005 /36/EC and

2. The heading to § 4 reads:

"Relationship with national and international authorities"

(3) The previous § 4 shall be replaced by the sales designation (1), the following paragraph 2 shall be added:

" (2) Within its sphere of action, the Austrian Pharmacists ' Chamber shall have the competent authorities of the other States Parties to the Agreement on the European Economic Area (the EEA States Parties) and the Swiss Confederation to the Application of Directive 2005 /36/EC on the recognition of professional qualifications necessary information in the context of crossborder administrative cooperation, where possible using the internet-based agency cooperation system IMI (Internal Market Information System) of the European Commission to grant and obtain information, in particular:

1.

Disciplinary, criminal or administrative measures relating to members of the Austrian Chamber of Pharmacists, or any other serious matter which affects the profession of pharmacist , and

2.

in respect of nationals of a pharmacist who are established in Austria and who wish to provide temporary services as pharmacists in another EEA State Party or the Swiss Confederation, on the legality of the Establishment and good management of the professional in Austria, as well as the fact that there are no professional disciplinary or criminal sanctions. "

4. § 30 (1) and (2) are:

" (1) All members of the Chamber of Pharmacists who are members of their profession in the constituency shall be entitled to vote without distinction of nationality, provided that they are not deprived of the right to vote of the Chamber of Pharmacists by means of disciplinary recognition. Legal persons shall exercise their right to vote by a representative who has been authorised by the competent institution of the legal person. A legal person has only one vote. Members of the Department of Hired Pharmacists may not be representatives of legal persons.

(2) All members of the Chamber of Pharmacists who are generally entitled to pursue the profession of pharmacist shall be eligible, without distinction of nationality, provided that they have not been deprived of eligibility by means of disciplinary recognition and provided that they are eligible for the exercise of the pharmacological profession. Eligibility is not excluded. "

Section 79 (2) reads as follows:

" (2) Decisions concerning the Rules of Procedure, the Function Fee Directive, the Pharmacoeexpulsion Directive, the Regulations, the Rules of Procedure, the Data Protection Regulation, the Professional Regulations and the Training Regulations and the Annual Estimate. and the closure of the accounts shall be immediately brought to the attention of the Federal Minister of Health, Family and Youth. "

Fischer

Gusenbauer