2021/0668/PL
EC/EFTA
PL Poland
  • C10P - Pharmaceuticals
2022-01-17
2021-10-27

Enabling the cultivation and harvesting of hemp other than fibrous hemp carried out, upon obtaining the authorisation of the Chief Pharmaceutical Inspector, by a research institute within the meaning of the Act of 30 April 2010 on research institutes (Journal of Laws of 2020, item 1383, as amended), supervised by the Minister responsible for agriculture with a view to producing the active substance referred to in Article 33a(1) of the Act on combating drug addiction.

Parliamentary draft Act amending the Act on combating drug addiction

According to the proposed amendment to the Act of 29 July 2005 on combating drug addiction (Journal of Laws of 2020, item 2050, as amended), it is proposed that:

— the authorisation for the cultivation and harvesting of hemp other than fibrous hemp for the purpose of producing the active substance referred to in Article 33a(1) of the Act on combating drug addiction be issued by the Chief Pharmaceutical Inspectorate by means of a decision, at the request of a research institute supervised by the Minister responsible for agriculture;
— the Chief Pharmaceutical Inspector request an opinion (issued in the form of a decision) of the provincial police command office (or the police command office for the city of Warsaw) competent for the place of cultivation covered by the application concerning the method of securing it against unauthorised access.
Moreover, the draft Act sets out the items to be included in the authorisation and the minimum infrastructure requirements to be met by the place of cultivation and harvesting of hemp other than fibrous hemp with a view to producing the active substance referred to in Article 33 of the Act on combating drug addiction.
In addition, the obligations of an authorised institute are laid down.
As per the solution proposed in the draft, the Chief Pharmaceutical Inspector will have the right to refuse to issue the authorisation if the institute does not fulfil the conditions referred to in paragraph 2, or does not guarantee that the harvesting of such crops is properly secured against use for purposes other than those specified in the Act, and in particular if they do not have land and premises protected against theft or destruction of the cultivated hemp.
Furthermore, it is proposed that, in the event of a breach of the operating conditions laid down in the Act or in the authorisation, that authorisation may be revoked.
Moreover, it is envisaged that the Chief Pharmaceutical Inspector will keep a register of issued licences.
In turn, a provincial pharmaceutical inspector will monitor the operating conditions and other conditions laid down in the Act on combating drug addiction and in the authorisation.
The draft Act proposes the establishment of a delegation to the Minister responsible for home affairs, who, after consulting the minister responsible for health, will lay down, by means of a regulation, the detailed criteria for assessing the securing of hemp other than fibrous hemp cultivated for the purpose of producing the active substance referred to in Article 33a(1) of the Act on combating drug addiction, with a view to ensuring that these
crops are properly protected against unauthorised access.