1-3 of 3 results for subject:Imports
Librarians' tools
- Search time
- 0.197 seconds
- Solr query time
- 0.006 seconds
- Search query
- subject:Imports
- We searched for
- subject_t:Imports OR subject_ses:91618
Type
House
Session
More
2004-05 (3)
Year
Department
Member
Primary member
Answering member
Legislative stage
Legislation
Subject
More
Licensing (3)
Publisher
To ask the Secretary of State for Environment, Food and Rural Affairs, what representations she received from (a) biotechnology companies, (b) environmental groups and (c) farming organisations regarding the application for a licence to import GT73 genetically modified oilseed rape into the European Union for use as animal feed (i)...
To ask the Secretary of State for Environment, Food and Rural Affairs, what representations she received from (a) biotechnology companies, (b) environmental groups and (c) farming organisations regarding the application for a licence to import GT73 genetically modified oilseed rape into the European Union for use as animal feed (i)...
Asked by
Andrew George
(Liberal Democrat)
Answered by
Elliot Morley
(Labour)
Answering body
Department for Environment, Food and Rural Affairs
Type
Written questions
Status
Answered
Tabled on
7 December 2004
For answer on
15 December 2004
Answered on
15 December 2004
Andrew George: To ask the Secretary of State for Environment, Food and Rural Affairs, what representations she received from
(a) biotechnology companies, (b) environmental groups and (c) farming organisations regarding the application
for a licence to import GT73 genetically modified oilseed rape into the European Union for use as animal feed (i) before and (ii)
after 20 June. [204158]
Mr. Morley: Defra Ministers have not, either before or after 20 June 2004, had any direct representations from biotechnology
companies, or farming organisations regarding this application. I have received one letter from an environmental organisation which
included, among other issues, a representation on this case. The Application by Monsanto Europe SA/NV for consent to import and
market oilseed rape grain GT73 under Directive 2001/18 was made through the Netherlands Competent Authority. As part of the
procedure there is a mandatory EU-wide system of written consultation for each commercial GM product application before any decision
is made. This provides all members of the public throughout the EU with the opportunity to make representations, which are taken
into account during the regulatory process. The UK authorities assessed the dossier after the Netherlands had submitted their
opinion and considered that further information was necessary before coming to a decision. Monsanto subsequently provided some
further information.
Subjects
Animal feed; Licensing; Genetically modified organisms; Imports; Oilseed rape
Date
15 December 2004
Reference
204158; 428 c1102-3W;428 c1103W
House
House of Commons
To ask the Secretary of State for Health, how many parallel traders have (a) been prosecuted, (b) been reprimanded and (c) had their licences revoked by the Medicines and Healthcare Products Regulatory Agency in each year since 2000.
To ask the Secretary of State for Health, how many parallel traders have (a) been prosecuted, (b) been reprimanded and (c) had their licences revoked by the Medicines and Healthcare Products Regulatory Agency in each year since 2000.
Asked by
Adrian Flook
(Conservative)
Answered by
Baroness Winterton of Doncaster
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
29 November 2004
For answer on
9 December 2004
Answered on
9 December 2004
Mr. Flook: To ask the Secretary of State for Health how many parallel traders have (a) been prosecuted, (b) been
reprimanded and (c) had their licences revoked by the Medicines and Healthcare Products Regulatory Agency in each year since
2000. [201683]
Ms Rosie Winterton: Records held by the Medicines and Healthcare products Regulatory Agency have identified that, from the
1 January 2000, no licensed wholesale dealers, who are involved in the business of parallel import trading of medicinal
products, have been prosecuted, or reprimanded, or have been issued a formal caution for a medicines legislation offence.
During the same period, four wholesale dealers that were involved in the business of parallel import trading of medicinal products
have had their wholesale dealer's licence revoked as a result of breaching the conditions of their licence.
Subjects
Licensing; Drugs; Imports; Prosecutions; Medicines and Healthcare products Regulatory Agency; Wholesale trade
Date
9 December 2004
Reference
201683; 428 c759W
House
House of Commons
To ask the Secretary of State for Health, what discussions he has had with parallel trade associations about possible risks to patient safety from re-packaged medicines; what discussions he has had with patient organisations regarding (a) parallel traded medicines and (b) substandard and poorly repackaged medicines.
To ask the Secretary of State for Health, what discussions he has had with parallel trade associations about possible risks to patient safety from re-packaged medicines; what discussions he has had with patient organisations regarding (a) parallel traded medicines and (b) substandard and poorly repackaged medicines.
Asked by
Adrian Flook
(Conservative)
Answered by
Baroness Winterton of Doncaster
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
29 November 2004
For answer on
9 December 2004
Answered on
9 December 2004
Mr. Flook: To ask the Secretary of State for Health (1) what discussions he has had with parallel trade associations about possible
risks to patient safety from re-packaged medicines; [201684]
(2) what discussions he has had with patient organisations regarding (a) parallel traded medicines and (b) substandard
and poorly repackaged medicines. [201685]
Ms Rosie Winterton: The Medicines and Healthcare products Regulatory Agency (MHRA) is in regular discussions with the parallel
importer's trade association (British Association of European Pharmaceutical Distributors), United Kingdom marketing authorisation
holders and individual parallel importers to discuss aspects of the packaging of imported medicines. This has generally been done on
a case-by-case basis if issues are identified or when new requirements or guidance are introduced. The agency has not had any formal
discussions with parallel trade associations regarding the possible risks to patient safety from re-packaged medicines from the
parallel trade in pharmaceuticals.
To date, the Medicines and Healthcare products Regulatory Agency (MHRA) has not received any representation from, nor had any
discussions with patient organisations regarding any substandard and poorly repackaged medicines from the parallel trade in
pharmaceuticals, nor has had any discussions specifically dealing with parallel trade in medicines.
The MHRA has received some letters from individual patients, patient carers and health professionals on the packaging of parallel
imports. In these cases, the product labelling and repackaging has been reviewed and, where appropriate, the parallel importer asked
to address the concern raised.
The agency has also met with the National Patient Safety Agency (NPSA) to advise them of its requirements relating to parallel
imports so that patients and their carers can have access to accurate information about these medicines.
In licensing parallel imports, the MHRA ensures the products comply with the appropriate regulations.
The repackaging of licensed medicinal products, such as parallel imports, is controlled by the specification registered in the
parallel import licence and may only be carried out by assembly sites licensed and inspected by the MHRA.
During the repackaging operation parallel importers are not permitted to change or interfere with the primary packaging of the
product--that is the immediate packaging in contact with the product itself (for instance the blister packaging). However to comply
with the ED labelling regulations as laid down in Title V of the Directive 2001/83/EC the importer is required to over label the
immediate packaging with certain details in English and to over label or replace the outer packaging to provide additional
information in English. Each product must also contain a patient information leaflet in English. These operations may be carried out
by the importer if the company holds an assembly licence, issued by MHRA after the inspecting the site. Any repackaging and
re-labelling proposed by a parallel importer is considered by MHRA before a parallel import licence is issued.
MHRA operates a Defective Medicines Report Centre (DMRC) which deals with reports of defects to all medicines, including parallel
imports. All reports made to the DMRC are investigated and where necessary, appropriate action taken.
MHRA would be happy to meet with any patient organisation to discuss parallel imports.
Subjects
Licensing; EU law; Drugs; Labelling; Imports; Patients; Pharmacy; Packaging; Regulation; Safety; Trade associations; Medicines and Healthcare products Regulatory Agency
Date
9 December 2004
Reference
428 c757-9W;428 c758-9W; 201684;201685
House
House of Commons