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1.
How is healthcare in your jurisdiction organised?
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2.
How is the healthcare system financed in the outpatient and inpatient sectors?
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3.
Which legislation governs advertising of medicinal products to the general public and healthcare professionals?
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4.
What are the main rules and principles applying to advertising aimed at healthcare professionals?
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5.
What are the main rules and principles applying to advertising aimed at the general public?
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6.
What are the most common infringements committed by manufacturers with regard to the advertising rules?
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7.
Under what circumstances is the provision of information regarding off-label use to healthcare professionals allowed?
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8.
Which legislation governs the collaboration of the pharmaceutical industry with healthcare professionals? Do different rules apply regarding physicians in the outpatient and inpatient sector?
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9.
What are the main rules and principles applying to the collaboration of the pharmaceutical industry with healthcare professionals?
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10.
What are the most common infringements committed by manufacturers with regard to collaboration with healthcare professionals?
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11.
What are the main rules and principles applying to the collaboration of the pharmaceutical industry with patient organisations?
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12.
Are manufacturers’ infringements of competition law pursued by national authorities?
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13.
Is follow-on private antitrust litigation against manufacturers possible?
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14.
What are the main mandatory anti-corruption and transparency rules applicable to pharmaceutical manufacturers?
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15.
Is the advertising of medical devices and the collaboration of manufacturers of medical devices with healthcare professionals and patient organisations regulated as rigorously as advertising and collaboration in the pharmaceuticals sector?
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16.
Which legislation sets out the regulatory framework for granting marketing authorisations and placing medicines on the market?
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17.
Which authorities may grant marketing authorisation in your jurisdiction?
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18.
What are the relevant procedures?
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19.
Will licences become invalid if medicinal products are not marketed within a certain time? Are there any exceptions?
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20.
Which medicines may be marketed without authorisation?
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21.
Are any kinds of named patient programmes in place? If so, what are the requirements for pre-launch access?
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22.
To what extent is the market price of a medicinal product governed by law or regulation?
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23.
Must pharmaceutical manufacturers negotiate the prices of their products with the public healthcare providers?
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24.
In which circumstances will the national health insurance system reimburse the cost of medicines?
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25.
If applicable, what is the competent body for decisions regarding the pricing and reimbursability of medicinal products?
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26.
Are manufacturers or distributors of medicinal products statutorily obliged to give a discount?
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27.
What rules are in place to counter the counterfeiting and illegal distribution of medicines?
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28.
What recent measures have been taken to facilitate the general public’s access to information about prescription-only medicines?
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29.
Outline major developments to the regime relating to safety monitoring of medicines.
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30.
Outline your jurisdiction’s vaccination regime for humans.
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