Pharmaceutical Technician Regulation

Original Language Title: Änderung der Pharmazeutischen Fachkräftverordnung

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360. Regulation of the Federal Minister of Health, which changes the Pharmaceutical Skilled Labour Regulation

Due to § 5 of the pharmacy law, RGBl. No. 5/1907, as last amended by the Federal Act BGBl. I n ° 135/2009, and section 2a (1) (6a) of the Pharmacerkammergesetz, BGBl. I n ° 111/2001, as last amended by the Federal Law BGBl. I No 64/2011, shall be arranged:

The Pharmaceutical Skilled Labour Regulation, BGBl. N ° 40/1930, as last amended by the BGBl Regulation. N ° 221/1971, shall be amended as follows:

1. § 1 (2) reads:

" (2) Hiezu belong:

1.

Generally professional pharmacists within the meaning of § 3b of the Pharmacies Act, RGBl. No 5/1907, as amended,

2.

Magistra/Magister der Pharmazie (Magistra/Magister der Pharmazie), who complete the one-year professional training in a public pharmacy or an anstaltsapotheke according to § 3a of the pharmacy law as amended (Aspirantin/Aspirant),

3.

persons who, as a compensatory measure pursuant to Section 3c (7) of the Pharmacy Act, choose a one-year professional training in a public pharmacy or an anstaltsapotheke in the applicable version, and

4.

Pharmacists who, in accordance with § 18, temporarily and occasionally as providers of services within the meaning of Directive 2005 /36/EC on the recognition of professional qualifications, OJ L 206, 22.7.2005, p. No. 22, as last amended by Regulation (EU) No 213/2011, OJ L 255, 30.9.2011, p. No. OJ L 59, 04.03.2011, p. 4.

2. § 1 (3).

3. In accordance with § 1, the following § 1a and title shall be inserted:

" General occupation

§ 1a. (1) The general professional qualification is required for the exercise of the pharmacists ' profession in Austria. Requirements for the granting of the general professional qualification by the Austrian Pharmacists 'Chamber are the State Pharmacists' Diploma or a training certificate according to § 3c of the Pharmacy Act, the reliability and the for the exercise the knowledge of the German language required by the pharmacist's profession.

(2) The existence of the conditions laid down in paragraph 1 shall be proven by the Austrian Chamber of Pharmacists prior to the commence of the professional activity, subject to the submission of the necessary documents. Within three months of the date on which the application, together with the required documents, has been submitted in full, the Austrian Chamber of Pharmacists shall, without delay, have the general right to work for the To grant a professional exercise.

(3) In the event that the conditions laid down in paragraph 1 do not exist, the general right to work shall be refused within a period of three months.

(4) The knowledge of the German language required for the exercise of pharmacists/pharmacists must be provided by a certificate of language examination, unless a five-year activity as a pharmacist in the German-speaking area, a German-speaking matura or a German-language course of study is shown. The positive certificate must be given in the language test of the "Austrian Language Diploma German (ÖSD)" in the difficulty level C1 or B2 (= Effective Proficiency).

(5) Pharmacists who are nationals of a Contracting Party to the Agreement on the European Economic Area or the Swiss Confederation may, in Austrian pharmacies, without prior grant of the general public Professional qualifications as provided for in paragraph 1 are temporarily and occasionally employed as providers of services within the meaning of the Directive on the recognition of professional qualifications. They shall be subject to the obligations laid down in § 18. "

4. § 2 para. 2 reads:

" (2) Aspirants and aspirants may be one of those in paragraph 1 lit. a and c are used only under the supervision of a pharmacist/pharmacist who is generally authorised to work. "

5. § 4 together with headline reads:

" Professional training

§ 4. (1) The required professional training (§ 5 (1)) must be carried out in suitable public pharmacies or in the local retail pharmacies.

(2) The person responsible for training/training is the pharmacist's/pharmacist. With this task, however, he/she can also entrust one/another pharmacist/pharmacist who is active in this pharmacy/is generally entitled to work.

(3) Only one aspirantin/aspirant may be trained in one operation. The training of a second aspirant/aspirant is, however, permissible if one aspirant/aspirant has interrupted his/her training or the training period has been extended by the examination board in accordance with Section 15 (1). The training of two aspirants in the half-service in accordance with § 5 para. 2 is also admissible.

(4) The pharmacist/pharmacist has the intended admission of an aspirant/aspirant one week before the beginning of the training relationship of the competent national office of the Austrian Pharmacists Chamber to report to the person responsible for training. Within one week from the date of notification, the State Secretariat shall check whether the pharmacy and the training officer are suitable for the training of aspirants/aspirants and the pharmacist/pharmacist leader from the result of their To be informed. If the pharmacy or the person responsible for the training is not suitable for the training of aspirants, the state office must inform the district administration authority and the pharmacist/pharmacist manager. The district administration authority shall prohibit the training if the pharmacy or the prospective training officer is not suitable for training.

(5) The pharmacist/pharmacist has to report the admission and the withdrawal of an aspirantin/aspirant within three days of the pharmaceutical payroll for Austria. The registration form is the birth certificate, the proof of citizenship and the obtaining of the academic degree of a Magistra/Magister of the Pharmacy or Pharmacy/Magister of the Pharmacy or Pharmacy. to the notification of the nostrification of a corresponding foreign study degree. The pharmaceutical payroll has to submit the data to the responsible state office and the Austrian Pharmacists ' Chamber. "

6. § 5 (2) and (3) reads as follows:

" (2) The Federal Minister of Health, after hearing the Austrian Pharmacists ' Chamber, may, for reasons worthy of consideration, such as, for example, care for a small child or long-term care of a close relative, the Training in half-service for a period of two years. A one-time change of the training service extent is permissible.

(3) The training period is limited to periods of time

1.

of the legal or of the collective-contractual leave and

2.

of service-prevention as a result of illness or accident up to a total duration of four weeks

"

7. In accordance with § 5 (3), the following paragraphs 4 to 7 are added:

' (4) The technical training shall be carried out without interruption, subject to the provisions of paragraph 5.

(5) An interruption of training is

1.

for periods of an employment ban according to § § 3 (1) to (3) and (5) (1) and (2) of the maternity protection act 1979, BGBl. N ° 221, as amended,

2.

for periods for which the Maternity Protection Act 1979, the Fathers Carenas Act, BGBl. No 651/1989, as amended, or similar Austrian legislation provides for a carence;

3.

for times of presence or training service according to the Wehrgesetz 2001, BGBl. I n ° 146, as amended, or civil service in accordance with the Civil Service Act 1986, BGBl. No 679, as amended, or

4.

for serious health, personal or family reasons

allowed.

(6) The Federal Minister of Health shall decide on the existence of an interruption in accordance with paragraph 5 Z 4 or on the admissibility of a total interruption more than three years in total, after hearing the Austrian Pharmacists ' Chamber.

(7) In the event of an inadmissible interruption, the periods of training completed shall not be counted and the technical training shall be started anew. '

8. § 6 reads:

" § 6. (1) The person responsible for the training has the obligation to train an aspirant/aspirant in all branches of the professional activity with care in his/her professional training and the activity of the aspirantin/aspirant to scrupulously supervise. The person responsible for the training can also entrust one/another general professional/professional pharmacist/pharmacist with regard to individual training contents.

(2) During the training period, the aspirant/aspirant of the training has to dedicate himself to the training for pharmacists/pharmacists. The Österreichische Apothekerkammer (Austrian Pharmacies Chamber) is to be notified of a further employment. The Austrian Chamber of Pharmacists shall prohibit the employment of further employment in a modest manner if it adversely affects the purpose of the technical training according to the nature or extent of the employment.

(3) Aspirants are to be employed until the end of the training period or to continue to employ them until the reexamination (§ 15) has been completed. "

9. § 7 (2) deleted, paragraph 3 receives the sales designation "(2)" and reads:

" (2) If the Office of the Austrian Pharmacists ' Chamber refuses to issue the certificate, this shall be done within one week after the date of submission of the certificate, stating the reasons for the certificate. The refusal of the certificate by the State Office of the Austrian Pharmacists ' Chamber may be challenged by the Aspirantin/Aspiranten as well as by the pharmacist/pharmacist by means of an appeal by means of which: the district administration authority decides. "

Section 8 (2) reads as follows:

" (2) The evidence has to contain:

1.

pre- and family/surname, place of birth, date of birth of the aspirantin/aspirants,

2.

Place and date of obtaining the academic degree of a Magistra/Magister of the pharmacy or date and university of the nostrification certificate of a corresponding foreign study degree,

3.

Date of admission of the aspirants/aspirants,

4.

The name and address of the pharmacy in which the professional training is completed, the name of the person responsible for training,

5.

the date of withdrawal from the pharmacy,

6.

Place and date of the successfully filed examination for the pharmacists/pharmacists. "

11. In Section 8 (3), the phrase "§ 4 (4)" through the phrase "§ 4 (5)" replaced.

§ 9 Abs.2 reads:

" (2) The competent national office of the Austrian Pharmacists ' Chamber has to inform the aspirant/aspirants and the persons responsible for the training/training responsible in writing within one week at the latest whether the application shall be taken note of, otherwise the application shall be rejected by the Austrian Chamber of Pharmacists in a modest manner within this period. A divergent communication from the Austrian Pharmacists ' Chamber may be appealed by the aspirantin/aspirant by means of appeal, which the district administration authority decides on. "

13. In § 9 (3), the phrase in the second sentence shall be: "the pharmacist who is entitled to training" through the phrase "the person responsible for training" replaced.

14. § 10 shall receive the title "Examination Commission" , (1) and (2) read:

" (1) The examination board consists of a pharmacist/pharmacist who is self-employed or employed as chairman/chairman and of a self-employed and employed pharmacist/pharmacist as examiner/examiner. A sufficient number of chairpersons and examiners must be ordered for each regional office of the Austrian Pharmacists ' Chamber.

(2) The senior medical officer/medical officer of the country or the deputy/deputy nominated by her/his/him may attend the examination for the supervision of the regularity of the examination procedure. "

15. § 10 (4) reads:

" (4) The State Office of the Austrian Pharmacists ' Chamber is entitled to assign one aspirant/aspirant of the Examination Commission to another branch office, if the aspirant/aspirant and those for examination in prospect shall agree to such an allocation. In this case, the request of the aspirantin/aspirant is to be sent for admission to the examination of the national office at which the examination is to take place. "

16. In Section 14 (1), the phrase "the government representative" through the phrase "the senior medical officer of the country or his/her deputy/deputy" deputy " replaced .

17. § 14 (3) reads:

" (3) The negotiation document shall be concluded with an overall assessment, for which the majority of the individual assessments carried out by the examiners/auditors shall be decisive. In the event of a tie, the chairman shall decide. The minutes are to be signed by the chairperson and the examiners. The result of the examination is the aspirantin/aspirant through a certificate (Annex) , which is to be issued by the competent regional office of the Austrian Pharmacists ' Chamber and which is to be completed by the chairman of the examination board. "

18. In accordance with § 15, the following § 15a and title shall be inserted:

" Compensatory measure according to § 3c of the pharmacy

§ 15a. (1) In accordance with Article 3c (7) of the German Pharmacies Act, the Austrian Pharmacists ' Chamber shall provide for a compensatory measure, the applicant may either have a one-year practical training in a public pharmacy, or To choose the pharmacy or the examination for the pharmacists ' profession.

(2) If the applicant chooses the one-year practical training as a compensatory measure, § § 2, 4 (1), 2, 4 and 5 as well as § § 5, 6, 7 (1) and (8) shall apply.

(3) If the applicant, as a compensatory measure, elects the examination for the pharmacist's profession, she/she has the right to apply for the examination at a national office. § § 10 to 15 shall apply mutatily. "

19. § § § 16 to 18 together with the headings are:

" Messages

§ 16. (1) The pharmacy manager/pharmacist has the beginning and end of a service relationship of a generally professional pharmacist/pharmacist or of a pharmacist acting on the basis of § 18 within three to report the working days of the Pharmaceutical Payroll. The reported data are to be transmitted to the Austrian Pharmacists ' Chamber.

(2) In Austrian pharmacies generally professional pharmacists and on the basis of § 18 active pharmacists are in evidence at the Österreichische Apothekerkammer (Austrian Pharmacists ' Chamber) and the pharmaceutical payroll. .

Line authority

§ 17. (1) For the purpose of calculating the duration of the five-year pharmaceutical activity in a pharmacy required for the authorisation of a pharmacy (management authorization), a service actually completed in full service shall be used. Reason to lay down. Periods completed in part-service shall be counted only in proportion to their relative share. In addition to the legally or collectively contractually stipulated leave, a six-month period of service prevention, which is not exceeded by a medical certificate, is credited by illness or accident.

(2) The authority loses the right of management who has not been active in any public pharmacy or in the Anstaltsapotheke for more than three years. The loss does not occur if a pharmaceutical activity in a public pharmacy or an anstaltsapotheke of a total of at least four weeks in full service, or if there is a lower level of service, a relatively longer duration is available within three years. The pharmaceutical activity may be distributed over the three-year period in such a way that the sum of the periods in three years is at least four weeks in full service.

(3) After the loss of the management authority, an activity lasting at least six months must be completed in full service for the purpose of regaining the right to regain.

Temporary service

§ 18. (1) Pharmacists who are nationals of a Contracting Party to the Agreement on the European Economic Area or the Swiss Confederation may, in Austrian pharmacies, without prior grant of the general public Professional authorization by the Austrian Chamber of Pharmacists temporarily and occasionally as a provider of services within the meaning of the Directive on the recognition of professional qualifications, if they are to exercise the Pharmacists/pharmacists lawfully in one of the listed Member States shall be established.

(2) The temporary and occasional nature of the provision of services referred to in paragraph 1 shall be assessed on a case-by-case basis, in particular on the basis of the duration, frequency, recurrence and continuity of the services provided for in paragraph 1. Provision of services. The knowledge of the German language required for the performance of the service must be available.

(3) A service provider within the meaning of paragraph 1 has, if he/she for the first time changes to Austria for the provision of services, to report this in writing to the Austrian Pharmacists ' Chamber in advance. This notification shall be renewed once a year if the service provider/service provider intends to provide services in Austria on a temporary or occasional basis during the year in question.

(4) If a prior notification is not possible due to the urgency of the action, the notification shall be made immediately, but no later than within one week of the beginning of the provision of the service. If services are provided for the first time or if there is a substantial change in relation to the situation certified in the documents, the service provider/provider of the Österreichische Apothekerkammer (Austrian Pharmacists ' Chamber)

1.

proof of their nationality,

2.

a certificate attesting that it is lawfully established in another Contracting Party to the Agreement on the European Economic Area or the Swiss Confederation for the purposes of exercising the pharmacists ' profession and that: you are not prohibited from exercising this profession at the time of presentation of the certificate, even temporarily, and

3.

her/his professional qualification

.

(5) The documents and certificates referred to in paragraph 3 in conjunction with paragraph 4 shall be submitted, if necessary, in certified translation, in the original or in certified copy and foreign-language documents. They may not be older than 12 months, except for the proof of professional qualification referred to in paragraph 4 (3) of this Directive. Information on details of insurance cover may be required from the provider/service provider within the meaning of paragraph 1.

(6) The provider/provider has the rights and obligations of a pharmacist/pharmacist when the service is provided in Austria. You/He shall be subject to the statutory and other provisions of the professional law and the applicable disciplinary provisions.

(7) In accordance with Article 56 of the Directive on the recognition of professional qualifications, the Austrian Chamber of Pharmacists and the Pharmaceutical Remuneration Fund may be a member of the competent authorities of another Contracting Party to the Agreement on the European Union. Economic Area or the Swiss Confederation for each provision of a service, request all information on the legality of the establishment and the good management of the service provider/provider as well as information on the non-existence of criminal law professional sanctions, withdrawal, revocation or renunciation of the profession as a disciplinary measure, the non-existence of a failure to carry out the activity and the absence of any facts which are one of those penalties, or Measures would be justified.

(8) At the request of the competent authorities of another Contracting Party to the Agreement on the European Economic Area or the Swiss Confederation, the Austrian Chamber of Pharmacists shall, in accordance with Article 56 of the Directive, have: Recognition of professional qualifications of the requesting authority all information on the legality of the establishment and the good management of the service provider/service provider, as well as information that no professional disciplinary or criminal sanctions are available, ,

(9) One of the nationals of a Contracting Party to the Agreement on the European Economic Area or the Swiss Confederation, which acts as a pharmacist/pharmacist who is a general professional/professional in Austria , shall, on request for the purpose of the provision of services in another Contracting Party to the Agreement on the European Economic Area or the Swiss Confederation, issue certificates to the effect that:

1.

she/he is entitled to exercise the pharmacist's profession in Austria,

2.

it is not prohibited, even temporarily, to carry out this activity at the time of the submission of the certificate, and

3.

she/he has a necessary professional qualification certificate. "

Article 20 (6) is deleted.

21. The installations designated as patterns A/1, A/2 and C shall be omitted and the installation shall be added.

Stöger