Search
There are 574 result(s) found based on your search criteria
1-10 from 574 result(s)
eSubmission
VNeeS Checker New versions (3.1) of the VNeeS checker are available for the electronic submission of marketing authorisation application files for medicines for veterinary use. From 1st January 2013 the files submitted in the framework of pre- and post‑authorisation procedures for medicines for veterinary use must be submitted electronically, in accordance with the nationa e-submission guideline . Since 1 st January 2010 the national competent authorities (NCAs) responsible for the evaluation of applications for marketing authorisation for medicines for veterinary use have been applying the eSubmission guideline . Two tools have been developed to facilitate this process. . File stricture
Licence - Registration
In application of Regulation (EC) No 273/2004, Council Regulation (EC) No 111/2005, Commission Delegated Regulation (EU) 2015/1011, (EU) 2015/1013 and Commission Delegated Regulation (EU) 2016/1443) and (EU)2018/729, operators shall hold a licence/registration when: engaged in import, export or intermediary activities, possession and/or placement on the market of substances category 1; in possession of substance category 2A and /or placement on the market of scheduled substances listed in category 2 in the EU; engaged in the import or export or intermediary activities involving of scheduled substances listed in category 2 or engaged in the export or intermediary activities involving of scheduled
Licence - Registration
In application of Regulation (EC) No 273/2004, Council Regulation (EC) No 111/2005, Commission Delegated Regulation (EU) 2015/1011, (EU) 2015/1013 and Commission Delegated Regulation (EU) 2016/1443) and (EU)2018/729, operators shall hold a licence/registration when: engaged in import, export or intermediary activities, possession and/or placement on the market of substances category 1; in possession of substance category 2A and /or placement on the market of scheduled substances listed in category 2 in the EU; engaged in the import or export or intermediary activities involving of scheduled substances listed in category 2 or engaged in the export or intermediary activities involving of scheduled
Authorisation import/export
Since 2 May 2006, a new system for the request and delivery of import and export authorisations is in place. Pursuant to Regulation (EC) No 273/2004, Council Regulation (EC) No 111/2005, Commission Delegated Regulation (EU) 2015/1011, (EU) 2015/1013 , (EU) 2016/1443) and Commission Delegated Regulation (EU)2018/729, the previous forms (KB 26/10/1993) for import and export authorisations have been replaced by new ones that better comply with the Regulations. The authorisations are delivered by the Drug Precursors Unit to interested parties. Requests must be made using the forms below: - Request for export authorisation - Request for import authorisation Applications for
Authorisation import/export
Since 2 May 2006, a new system for the request and delivery of import and export authorisations is in place. Pursuant to Regulation (EC) No 273/2004, Council Regulation (EC) No 111/2005, Commission Delegated Regulation (EU) 2015/1011, (EU) 2015/1013 , (EU) 2016/1443) and Commission Delegated Regulation (EU)2018/729, the previous forms (KB 26/10/1993) for import and export authorisations have been replaced by new ones that better comply with the Regulations. The authorisations are delivered by the Drug Precursors Unit to interested parties. Requests must be made using the forms below: - Request for export authorisation - Request for import authorisation Applications for
Precursors
Legislation - Background Licence - Registration Authorisation import/export Letter Of No Objection (LONO) Central contact point Identity theft Destruction
Precursors
Legislation - Background Licence - Registration Authorisation import/export Letter Of No Objection (LONO) Central contact point Destruction
Central contact point
Drug precursors are substances which can be used in illicit manufacture of narcotic drugs and psychotropic substances. Illicit manufacture of drugs can, at times, intersect with legal trade, as a large number of the substances necessary for their manufacture can be sourced from regular trading. Furthermore, an increasing numbers of criminals obtain their supplies through retail stores and pharmacies. Market monitoring of certain substances by the competent public authorities is therefore a key element in the fight against the illicit manufacture of drugs. EU legislations (Regulation (EC) No 273/2004, Council Regulation (EC) No 111/2005, Commission Delegated Regulation (EU) 2015/1011, (EU)
Central contact point
Drug precursors are substances which can be used in illicit manufacture of narcotic drugs and psychotropic substances. Illicit manufacture of drugs can, at times, intersect with legal trade, as a large number of the substances necessary for their manufacture can be sourced from regular trading. Furthermore, an increasing numbers of criminals obtain their supplies through retail stores and pharmacies. Market monitoring of certain substances by the competent public authorities is therefore a key element in the fight against the illicit manufacture of drugs. EU legislations (Regulation (EC) No 273/2004, Council Regulation (EC) No 111/2005, Commission Delegated Regulation (EU) 2015/1011, (EU)
Information for travellers
If you are travelling and your medicine contains a substance referred to in the Royal Decree of 06/09/2017 regulating narcotic and psychotropic substances, you will need an official accompanying document proving that you were prescribed these medicines as part of a medical treatment. To find out which medicines are targeted by this Belgian legislation, you can ask your doctor or pharmacist for advice or consult this list of substances . Examples of medicinal products containing substances on this list: Sleep-inducing medicines and sedatives; Strong analgesics (e.g. analgesics containing morphine); Medicines for the treatment of ADHD (e.g. medicines containing the active