1. When did the new legal requirements enter into force?
On 31-Dec-2009, the amendment to the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG), Official Federal Gazette I No. 146/2009, entered into force, and with it the new Art 16 para 5 (4) AMG.
Excerpt from the Austrian Medicinal Products Act [Art 16 para 5 (4)]:*
‘In addition to the information provided in accordance with para 2 and para 4, the patient leaflet of proprietary medicinal products containing illicit active substances in accordance with Art 1 para 2 of the Federal Anti-Doping Act (Anti-Doping-Bundesgesetz) 2007, Official Federal Gazette I No. 30, shall contain the following note: „Die Anwendung des Arzneimittels [Bezeichnung des Arzneimittels einsetzen] kann bei Dopingkontrollen zu positiven Ergebnissen führen.“ (‘Use of the medicinal product [insert name of the medicinal product] can lead to positive results in doping tests.’) If misuse of the proprietary medicinal product for doping purposes may pose a risk to health, an additional note to this effect shall be included. These requirements do not apply to proprietary medicinal products pursuant to Art 9b.’
2. What is the deadline for implementing these new requirements?
New marketing authorisations already have to conform to these requirements.
For existing marketing authorisations, the transitional provision of Art 94g applies. Thus, for medicinal products already approved, the doping warning must have been implemented as a notifiable change in accordance with Art 24 para 6 of the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG) by not later than 31-Dec-2010.
Excerpt from the Austrian AMG [Art 94g]:*
‘Revisions of patient leaflets of proprietary medicinal products approved or registered before the entry into force of this federal act as amended by the Official Federal Gazette I No. 146/2009 that serve the purpose of fulfilling the requirements of Art 16 para 5 (4) shall be performed by not later than the end of 31-Dec-2010. This amendment shall be considered a notifiable amendment in accordance with Art 24 para 6.’
3. Which medicinal products are affected by the new legal requirements?
In principle, Art 16 para 5 (4) applies to all medicinal products containing a substance listed in Annex I of the International Convention against Doping in Sport (Official Federal Gazette III Nr. 229/2014). This Prohibited List is regularly adapted in accordance with the state of scientific knowledge.
Excluded are medicinal products manufactured using a homoeopathic process technology. The obligation to include a warning statement applies irrespective of whether prohibition of the substance is subject to specific threshold limits, sex-specific limitations, or applies only to administration of the substance ‘in competition’ or ‘in competition in certain sports’. Also, it is irrelevant whether the substance contained in the proprietary medicinal product is qualified as an active ingredient or an excipient.
Prohibited List (Verbotsliste)
4.The substances contained in my proprietary medicinal product are not listed in the Prohibited List. Does this mean that no anti-doping warning is required for my product?
The Prohibited List is merely meant to provide assistance and is not exhaustive. Ultimately, the marketing authorisation holder will have to determine whether a substance falls into any of the categories of the List; if so, an anti-doping warning must be included, even if the substance concerned is not explicitly mentioned in the List.
5. How should the new provision be implemented?
A pertinent warning is to be included in section 2 of the patient leaflet above ‘Other medicines and X.’ For better orientation, a subheading may be included:
„Die Anwendung des Arzneimittels [Bezeichnung des Arzneimittels einsetzen] kann bei Dopingkontrollen zu positiven Ergebnissen führen.“ (‘Use of the medicinal product [insert name of the medicinal product] can lead to positive results in doping tests.’)
If misuse of the medicinal product for doping purposes may pose a risk to health and a relevant explanation is medically required, this can also be included in this paragraph.
6. Does the warning to be included in the patient leaflet (PL) also have to be included in the summary of product characteristics (SmPC)?
No, Art 16 para 5 (4) of the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG) does not explicitly require the warning to be included in the SmPC; the legislation merely talks about the PL.
7. If I take advantage of the transitional provision of Art 16b of the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG) for my proprietary medicinal product and, as a result, use the SmPC rather than the PL as package insert, do I have to include
Yes, in this case, the warning must be included in the SmPC if the criteria for inclusion of the warning are fulfilled.
The transitional periods specified in Art 94f para 4 apply.
Excerpt from the Austrian Medicinal Products Act [Art 94f para 4]:*
’Proprietary medicinal products which, in accordance with Art 16b in the version in force before the entry into force of this federal law in the version of the Official Federal Gazette I No. 63/2009, were actually able to be placed on the market without a patient leaflet, have to fulfil the requirement of a patient leaflet until the expiry of 31-Dec-2014. On duly motivated request, the Federal Office for Safety in Health Care can extend this period.’
8. Do the new provisions also apply to marketing authorisations from mutual recognition procedures (MRPs) and decentralised procedures (DCPs)?
For affected medicinal products for which the marketing authorisations have already been granted in either an MRP or DCP, the patient leaflet (PL) has to be amended as stipulated. The change has to be notified to the Federal Office for Safety in Health Care (BASG).
For marketing authorisation procedures that are still ongoing, the amended PL will be approved as part of the dossier.
Reference: CMDh/258/2012/Rev.6 July 2015
9. Do these new provisions apply to parallel-imported medicinal products?
10. If the regulation is also to be applied to centralised procedures?
Yes, as an object of the 'blue box'.
Reference: Notice to Applicants, Guideline on the Packinging Information of Medicinal Products for human use authorised by the Union Revision 14.3
11. Do the new provisions apply to unapproved investigational medicinal products intended for use in clinical trials?
12. According to the WHO Prohibited List (M2.2), intravenous infusion is a prohibited method. Do all intravenously administered proprietary medicinal products automatically require an anti-doping note?
No, only when they contain at least one substance contained in the Prohibited List.
Created: 15.02.2010 | Page last modified: 08.03.2016