Notification Detail

Draft Decree laying down the conditions for prescribing, preparing, dispensing and using magistral medicinal products containing cannabis for medical use

Notification Number: 2013/288/CZ (Czech Republic)
Date received: 30/05/2013
End of Standstill: 19/06/2013
Invocation of the Emergency Procedure: Yes

bg cs da de el en es et fi fr hu it lt lv mt nl pl pt ro sk sl sv
cs de en fr
cs
bg cs da de el en es et fi fr hu it lt lv mt nl pl pt ro sk sl sv


Message 002

Communication from the Commission - TRIS/(2013) 01392
Directive 98/34/EC
Translation of the message 001
Notification: 2013/0288/CZ

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Nao inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 201301392.EN)


1. Structured Information Line
MSG 001 IND 2013 0288 CZ CS 30-05-2013 CZ NOTIF


2. Member State
CZ


3. Department Responsible
Úřad pro technickou normalizaci, metrologii a státní zkušebnictví
Gorazdova 24, 128 01 Praha 2
tel: +420 224 907 139
fax: +420 224 907 122
e-mail: eu9834@unmz.cz


3. Originating Department
Ministerstvo zdravotnictví České republiky


4. Notification Number
2013/0288/CZ - C10P


5. Title
Draft Decree laying down the conditions for prescribing, preparing, dispensing and using magistral medicinal products containing cannabis for medical use


6. Products Concerned
Active substances and excipients that may be used for the preparation of medicinal products


7. Notification Under Another Act
-


8. Main Content
Definition of the types and quantities of cannabis that may be prescribed and used in the preparation and dispensing of magistral medicinal products.

Key words: medicinal products, cannabis


9. Brief Statement of Grounds
This draft Decree was prepared as a result of public pressure and requests from the addressees of this legislation to allow for the medical use of cannabis. Amendments to the Drugs Act and the Act on Addictive Substances have been adopted that allow for the use of cannabis in the preparation of magistral medicinal products. The proposed Decree specifies the type and quantities of cannabis to be used.


10. Reference Documents - Basic Texts
References to basic texts: - Act No 378/2007 Coll. on drugs and on amendments to certain related acts
- Act No 167/1998 Coll. on addictive substances and on amendments to certain other acts, as amended
- Act No 50/2013 Coll. amending Act No 378/2007 Coll. on drugs and on amendments to certain related acts (the Drugs Act), as amended, Act No 167/1998 Coll. on addictive substances and on amendments to certain other acts, as amended, and Act No 634/2004 Coll. on administrative fees, as amended.
The basic texts were submitted with an earlier notification: 2013/0236/CZ


11. Invocation of the Emergency Procedure
Yes


12. Grounds for the Emergency
Grounds for the emergency:
As stated under point 8 of the notification form, amendments to the Drugs Act and the Act on Addictive Substances were adopted on the initiative of MPs. The amendments to the above acts allow for the use of cannabis in magistral medicinal products for medical use.
The reason for the emergency is that the amendments need to be urgently “brought to life”, including by means of the present draft Decree, so that certified pharmacies may prepare cannabis-containing medicinal products and significantly reduce illegal sale of these products.
Any further delay threatens the health of patients who buy illegally prepared products of unspecified and, above all, unknown cannabinoid content. This situation promotes illegal cannabis cultivation and trafficking, which is linked with other criminal activities associated with organised crime.


13. Confidentiality
No


14. Fiscal measures
No


15. Impact assessment
Yes


16. TBT and SPS aspects
The aspect of technical barriers to trade (TBT)

No - the draft has no significant impact on international trade.

The aspect of sanitary and phytosanitary measures (SPS)

No – the draft is not a sanitary or phytosanitary measure.

No - the draft has no significant impact on international trade.



**********
Evropská komise

Kontaktní bod směrnice 98/34/ES
Fax: +32 229 98043
email: dir83-189-central@ec.europa.eu

Stakeholders Contributions

The TRIS website makes it easy for you or your organization to contribute with your opinion on any given notification.
Due to the end of standstill we are currently not accepting any further contributions for this notification via the website.


No contributions were found for this notification