January 2012
3 February 2012: Publication of assessment reports for European Article 45/46 paediatric work-sharing procedures.
On 30 January 2012, CMDh published paediatric assessment reports following completion of three Article 45 work-sharing procedures (external link). The work-sharing assessment reports include recommendations for changes in the product information for the following active substances:
January 2012
Fenofibrate
Minoxidil
Phenoxymethylpenicillin
Regulatory actions are required for all of the above mentioned Art 45 products.
No assessment reports have been published in January 2012 for Article 46 work-sharing procedures (external link).
Marketing authorisation holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substances in accordance with the recommendations in the work-sharing reports.
The relevant national or mutual recognition procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010.
Further guidance for submitting these applications to the MHRA was announced on 4 February 2011. In accordance with the CMDh Best Practice Guidance, these variations should be submitted with 90 days of the publication of the assessment report (external link). Any enquiries about submission of these variations should be addressed to specialpopulationsunit@mhra.gsi.gov.uk
November 2011
On 25 November 2011, CMDh published paediatric assessment reports following completion of two Article 45 work-sharing procedures (external link). The work-sharing assessment reports include recommendations for changes in the product information for the following active substances:
November 2011
Acarbose
Thiamazole (not marketed in UK)
Regulatory actions are required for both of the above mentioned Art 45 products.
No assessment report had been published in November 2011 for Article 46 work-sharing procedures (external link).
Marketing authorisation holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substances in accordance with the recommendations in the work-sharing reports.
The relevant national or mutual recognition procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010.
Further guidance for submitting these applications to the MHRA was announced on 4 February 2011. In accordance with the CMDh Best Practice Guidance, these variations should be submitted with 90 days of the publication of the assessment report (external link). Any enquiries about submission of these variations should be addressed to specialpopulationsunit@mhra.gsi.gov.uk
September 2011
On 30th September 2011, CMDh published paediatric assessment reports following completion of three Article 45 work-sharing procedure (external link).
September 2011
August 2011
In early August 2011, CMDh published one paediatric assessment report following completion of an Article 45 work-sharing procedure (external link). The work-sharing assessment reports include recommendations for changes in the product information for the following active substances:
Regulatory actions are required for the above mentioned Article 45 products. Furthermore, two assessment reports have been published in August 2011 following the completion of the respective Article 46 work-sharing procedures (external link). The products are:
August 2011
Neurontin (Gabapentin)
Strattera (Atomoxetine) (UK/W/010/PdWS/003)
Regulatory actions are not required for both the above mentioned Article 46 products.
Marketing authorisation holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substance in accordance with the recommendations in the work-sharing reports.
The relevant national or mutual recognition procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010.
Further guidance for submitting these applications to the MHRA was announced on 4 February 2011. In accordance with the CMDh Best Practice Guidance, these variations should be submitted with 90 days of the publication of the assessment report (external link). Any enquiries about submission of these variations should be addressed to specialpopulationsunit@mhra.gsi.gov.uk
July 2011
8 July 2011: Publication of assessment reports for European Article 45 paediatric work-sharing procedures
Alendronic acid
July 2011
Xatral (Alfuzocin)
Afluria/Enzira (Influenza vaccine)
Famvir and associated names (famciclovir) (DE/W/005/pdWS/002)
Regulatory actions are required for Xatral (Alfuzocin) in the above mentioned Art 46 products.
Marketing authorisation holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substance in accordance with the recommendations in the work-sharing reports.
The relevant national or mutual recognition procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010.
June 2011
9 June 2011: Publication of assessment reports for European Article 45 paediatric work-sharing procedures
Clindamycin
Ipratropium
Ipratropium/Salbutamol
Flumazenil
Montelukast (Singulair)
Pimecrolimus (Elidel)
April 2011
26 May 2011: Publication of assessment reports for European Article 45 paediatric work-sharing procedures
Propranolol
Clonidine
Glimepiride (Amaryl)
POLIORIX (Inactivated Polio Virus (IPV) Type 1, Inactivated Polio Virus (IPV) Type 2, Inactivated Polio Virus (IPV) Type 3)
Marketing authorisation holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substance in accordance with the recommendations in the work-sharing reports.
March 2011
3 May 2011: Publication of assessment reports for European Article 45 paediatric work-sharing procedures
In late March 2011, CMDh published paediatric assessment reports following completion of three Article 45 work-sharing procedure (external link). The work-sharing assessment reports include recommendations for changes in the product information for the following active substances:
Metoclopramide
Itraconazole
Ethosuximide
Amiodarone
March 2011
Tetravac/Tetraxim
Somatropin (Norditropin)
In early March 2011, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published two paediatric assessment report following completion of Article 45 work-sharing procedure (external link). The work-sharing assessment report include recommendations for changes in the product information for the following active substance:
Human normal immunoglobulin
Topiramate
Montelukast (Singulair)
The relevant national or mutual recognition procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010.
Further guidance for submitting these applications to the MHRA was announced on 4 February 2011. In accordance with the CMDh Best Practice Guidance, these variations should be submitted with 90 days of the publication of the assessment report (external link). Any enquiries about submission of these variations should be addressed to specialpopulationsunit@mhra.gsi.gov.uk.
February 2011
7 February 2011: Publication of assessment reports for European Article 45 paediatric work-sharing procedures
In late January 2011, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published five more paediatric assessment report following completion of Article 45 work-sharing procedure (external link). The work-sharing assessment report include recommendations for changes in the product information for the following active substance:
Regulatory actions are required for the above mentioned procedure.
Marketing authorisation holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substance in accordance with the recommendations in the work-sharing reports.
The relevant national or mutual recognition procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010.
Further guidance for submitting these applications to the MHRA was announced on 4 February 2011. In accordance with the CMDh Best Practice Guidance, these variations should be submitted with 90 days of the publication of the assessment report (external link). Any enquiries about submission of these variations should be addressed to specialpopulationsunit@mhra.gsi.gov.uk.
4 Feb 2011: Updated guidance: Variations to implement changes to product information following European paediatric work-sharing procedures
We have updated our guidance for marketing authorisation holders on the need to update product information following the recommendations of European paediatric work-sharing procedures.
January 2011
12 January 2011: Publication of assessment reports for European Article 45 and 46 paediatric work-sharing procedures
In early January 2011, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published five more paediatric assessment report following completion of Article 45 work-sharing procedure (external link). The work-sharing assessment report include recommendations for changes in the product information for the following active substance:
January 2011
Apis mellifera, lyophilised venom
Vespula spp., lyophilised wasp venom (allergens)
Remifentanil
Metronidazole / Metronidazole + Spiramycin
Mepivacaine
Regulatory actions are required for all of the above mentioned procedures
Furthermore, four assessment report had been published in January 2011 following the completion of the respective Article 46 work-sharing procedures (external link). The active substances are:
January 2011
Salmeterol xinafoate, Fluticasone propionate (Seretide)
Adartrel (ropinirole)
Aricept (Donepezil)
Esomeprazole (Nexium)
No regulatory actions are required for Aricept (Donepezil) of the above mentioned procedures.
Marketing authorisation holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substance in accordance with the recommendations in the work-sharing reports.
The relevant national or Mutual Recognition Procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010.
Further guidance for submitting these applications to the MHRA was announced on 10 February 2010. In accordance with the CMDh Best Practice Guidance (external link), these variations should be submitted with 90 days of the publication of the assessment report.
Any enquiries about submission of these variations should be addressed to specialpopulationsunit@mhra.gsi.gov.uk.
5 January 2011: Publication of assessment reports for European Article 45 and 46 paediatric work-sharing procedures
November 2010
In November 2010, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published three more paediatric assessment report following completion of Article 45 work-sharing procedure (external link). The work-sharing assessment report include recommendations for changes in the product information for the following active substance:
November 2010
Clarithromycin
Diclofenac
Levofloxacin
Regulatory actions are required for Clarithromycin and Diclofenac of the above mentioned procedures.
Furthermore, two assessment reports had been published in November 2010 following the completion of the respective Article 46 work-sharing procedures (external link).
The active substances are:
November 2010
Elidel (pimecrolimus) - DK/W/007/pdWS/002
Genotropin and associated names (somatropin)
No regulatory actions are required for Elidel (pimecrolimus) and Genotropin and associated names (somatropin) of the above mentioned procedures.
Marketing authorisation holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substance in accordance with the recommendations in the work-sharing reports.
The relevant national or Mutual Recognition Procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010.
Further guidance for submitting these applications to the MHRA was announced on 10 February 2010. In accordance with the CMDh Best Practice Guidance (external link), these variations should be submitted with 90 days of the publication of the assessment report.
Any enquiries about submission of these variations should be addressed to specialpopulationsunit@mhra.gsi.gov.uk.
5 November 2010: Publication of assessment reports for European Article 45 and 46 paediatric work-sharing procedures
October 2010
In late October 2010, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published three more paediatric assessment report following completion of Article 45 work-sharing procedures (external link). The work-sharing assessment report include recommendations for changes in the product information for the following active substance:
October 2010
Loratadine
Melphalan
Neridronic acid
Regulatory action is required for Neridronic acid of the above mentioned procedures.
Furthermore, one assessment report had been published in October 2010 following the completion of the respective Article 46 work-sharing procedures (external link). The active substance is:
October 2010
Depakin and associated names (sodium valproate)
Marketing authorisation holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substance in accordance with the recommendations in the work-sharing reports.
The relevant national or Mutual Recognition Procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010. Further guidance for submitting these applications to the MHRA was announced on 10 February 2010.
In accordance with the CMDh Best Practice Guidance (external link), these variations should be submitted with 90 days of the publication of the assessment report.
Any enquiries about submission of these variations should be addressed to specialpopulationsunit@mhra.gsi.gov.uk
3 November 2010: Updated assessment reports for European Article 45 paediatric work-sharing procedures
On 18 October 2010, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published an updated Article 45 work-sharing procedures (external link) assessment report for Gentamicin sulphate. This report replaces the one previously published in February 2010.
19 October 2010: Publication of assessment reports for European Article 45 paediatric work-sharing procedures
In October 2010, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published a paediatric assessment report following completion of five Article 45 work-sharing procedures (external link). The work-sharing assessment report includes recommendations for changes in the product information for the following active substances:
October 2010
Chondroitin
Famciclovir
Oxybutinin
Risedronate
Triptorelin
Regulatory action is required for all of the above mentioned procedures.
Marketing authorisation holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substance in accordance with the recommendations in the work-sharing reports.
The relevant national or Mutual Recognition Procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010. Further guidance for submitting these applications to the MHRA was announced on 10 February 2010.
In accordance with the CMDh Best Practice Guidance (external link), these variations should be submitted with 90 days of the publication of the assessment report.
Any enquiries about submission of these variations should be addressed to specialpopulationsunit@mhra.gsi.gov.uk
September 2010
8 September 2010: Publication of assessment reports for European Article 45 paediatric work-sharing procedures
In September 2010, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published a paediatric assessment report following completion of one Article 45 work-sharing procedures (external link). The work-sharing assessment report includes recommendations for changes in the product information for the following active substance:
September 2010
Propofol
Regulatory action is required for this procedure.
Marketing authorisation holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substance in accordance with the recommendations in the work-sharing reports.
The relevant national or Mutual Recognition Procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010. Further guidance for submitting these applications to the MHRA was announced on 10 February 2010.
In accordance with the CMDh Best Practice Guidance (external link), these variations should be submitted with 90 days of the publication of the assessment report.
Any enquiries about submission of these variations should be addressed to specialpopulationsunit@mhra.gsi.gov.uk
August and July 2010
11 August 2010: Publication of assessment reports for European Article 45 and 46 paediatric work-sharing procedures
In July/August 2010, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published paediatric assessment reports following completion of eight Article 45 work-sharing procedures (external link). The work-sharing assessment reports include recommendations for changes in the product information for the following active substances:
July 2010
Ciclosporin
Filgrastim
Mianserin
August 2010
Amoxicillin / Amimox*
Amoxicillin / Clavulanic Acid
Canis familiaris / Felis domesticus*
Mirtazapine*
Phleum pratense*
* Regulatory actions are required for these procedures.
Furthermore, four assessment reports had been published in July/August 2010 following the completion of the respective Article 46 work-sharing procedures (external link). The active substances are:
July 2010
Kytril (granisetron)
Prograf (tacrolimus)
August 2010
Agopton (lansoprazole)*
Famvir and associated names (famciclovir)
* Regulatory actions are required for this procedure.
Marketing authorisation holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substances in accordance with the recommendations in the work-sharing reports.
The relevant national or Mutual Recognition Procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010. Further guidance for submitting these applications to the MHRA was announced on 10 February 2010.
In accordance with the CMDh Best Practice Guidance (external link), these variations should be submitted with 90 days of the publication of the assessment report.
Any enquiries about submission of these variations should be addressed to specialpopulationsunit@mhra.gsi.gov.uk
June 2010
16 June 2010: Report to the European Commission on benefits from the Paediatric Regulation
The MHRA would like to draw attention to the recently published report to the European Commission on companies and products that have benefited from rewards and incentives in the Paediatric Regulation.
Report on rewards and incentives under the Paediatric Regulation (external link).
This report has been prepared by the Paediatric Medicines Section at the EMA and compiles information submitted by member states, including the UK. The report shows that companies and products are beginning to benefit from its rewards and incentives three years after the Regulation came into force.
Two products had received the reward of six-month extension to Supplementary Protection Certificates for their patents at the time the information was collated - other extensions are expected shortly. No specific failures to comply with the obligations of the Regulation are reported, although areas for monitoring are noted.
In particular, the MHRA would like to remind companies that text should be included in section 5.1 of the summary of product characteristics (SmPC) (and, if judged appropriate in the package leaflet) where a product has received a waiver or deferral for a paediatric investigation plan when a marketing authorisation is granted initially or when it is varied to include new indications, pharmaceutical forms or routes of administration.
Appropriate forms of text are proposed in the SmPC Guideline published by the EMA (external link).
For further information, please contact the specialpopulationsunit@mhra.gsi.gov.uk
10 June 2010: Publication of assessment reports for European Article 45 and 46 paediatric work-sharing procedures
May 2010
In May 2010, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published paediatric assessment reports following completion of three Article 45 work-sharing procedures (external link). The work-sharing assessment reports include recommendations for changes in the product information for the following active substances:
May 2010
Beclomethasone (inhaled product)
Dermatophagoides pteronyssinus/farinae
Sevoflurane
It is noted that no regulatory action is required for beclomethasone or sevoflurane. Please refer to the assessment report for the recommendations for Dermatophagoides pteronyssinus/farinae.
Furthermore, two assessment reports had been published in April 2010 following the completion of the respective Article 46 work-sharing procedures (external link). No further regulatory action is required as a result of these procedures. The active substances are:
April 2010
Elidel (pimecrolimus)
Strattera (atomoxetine)
Marketing authorisation holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substances in accordance with the recommendations in the work-sharing reports.
The relevant national or Mutual Recognition Procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010. Further guidance for submitting these applications to the MHRA was announced on 10 February 2010.
In accordance with the CMDh Best Practice Guidance (external link), these variations should be submitted with 90 days of the publication of the assessment report.
Any enquiries about submission of these variations should be addressed to specialpopulationsunit@mhra.gsi.gov.uk.
17 May 2010: Publication of assessment reports for European Article 45 paediatric work-sharing procedures
April 2010
In April 2010, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published paediatric assessment reports following completion of three Article 45 work-sharing procedures (external link). The work-sharing assessment reports include recommendations for changes in the product information for the following active substances:
April 2010
Betula verrucosa (Allergen extracts from birch/alder/hazel)
Paclitaxel
Rifaximin
Marketing authorisation holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substances in accordance with the recommendations in the work-sharing reports.
The relevant national or Mutual Recognition procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010. Further guidance for submitting these applications to the MHRA was announced on 10 February 2010.
In accordance with the CMDh Best Practice Guidance (external link), these variations should be submitted with 90 days of the publication of the assessment report.
Any enquiries about submission of these variations should be addressed to specialpopulationsunit@mhra.gsi.gov.uk.
23 April 2010: Publication of assessment reports for European Article 45 paediatric work-sharing procedures
In March 2010, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published paediatric assessment reports following completion of four Article 45 work-sharing procedures (external link). The work-sharing assessment reports include recommendations for changes in the product information for the following active substances:
March 2010
Fentanyl
Levothyroxine
Mesalazine
MA holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substances in accordance with the recommendations in the work-sharing reports.
The relevant national or mutual recognition procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010. Further guidance for submitting these applications to the MHRA was announced on 10 February 2010.
In accordance with the CMDh Best Practice Guidance (external link), these variations should be submitted with 90 days of the publication of the assessment report.
The report for ranitidine also published in March 2010 does not make any recommendations further to those published in 2007 as a result of the previous EU paediatric work-sharing project (external link).
Any enquiries about submission of these variations should be addressed to specialpopulationsunit@mhra.gsi.gov.uk.
4 March 2010: Publication of assessment reports for European Article 45 paediatric work-sharing procedures
In February 2010, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published paediatric assessment reports following completion of two Article 45 work-sharing procedures (external link). The work-sharing assessment reports include recommendations for changes in the product information for the following active substances:
February 2010
Amikacin
Gentamicin
MA holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substances in accordance with the recommendations in the work-sharing reports.
The relevant national or mutual recognition procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010. Further guidance for submitting these applications to the MHRA was announced on 10 February 2010.
In accordance with the CMDh Best Practice Guidance (external link), these variations should be submitted with 90 days of the publication of the assessment report.
3 March 2010: Paediatric assessment work in the MHRA
Paediatric Regulation (Regulation EC No.1901/2006 as amended) has introduced certain regulatory procedures which are unique to the use of medicines in children. Information as to how this effects assessment work, conducted by the Special Populations Group in the VRMM Division, has been added to the medicines for children section of the website.
11 February 2010: Updated guidance on requirements for paediatric 'compliance checks' during validation
We have previously published guidance on how the MHRA will handle the impact of the requirements of the Paediatric Regulation on the validation of applications for marketing authorisations (MAs). The guidance has been updated to reflect the need for compliance checks on certain line extensions and variations as well as initial applications for new medicinal products.
10 February 2010:Publication of assessment reports for European Article 45 paediatric work-sharing procedures
In November 2009 and January 2010, CMDh published paediatric assessment reports following completion of a number of Article 45 work-sharing procedures (external link). The work-sharing assessment reports include recommendations for changes in the product information for the following active substances:
November 2009
Amlodipine
Felodipine
Glucosamine
Lisinopril
January 2010
Bisacodyl
Colestyramine
Tranexamic acid
Market authorisation holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substances in accordance with the recommendations in the work-sharing reports.
The relevant national or mutual recognition procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010. Further guidance for submitting these applications to the MHRA was announced on 10 February 2010.
In accordance with the CMDh best practice guidance, these variations should be submitted with 90 days of the publication of the assessment report.
10 February 2010: Variations to implement changes to product information following European paediatric work-sharing procedures: New guidance with immediate effect
We have updated our guidance for marketing authorisation holders on the need to update product information following the recommendations of European paediatric work-sharing procedures.
12 January 2010: MHRA exercise to update product information following European paediatric work-sharing procedures
Following our announcement on 18 November 2008, requests have now been sent to marketing authorisation (MA) holders for products containing oxazepam where product information has not already been updated. Further information is available in the Medicines for Children section of our website.
2009
16 December 2009: MHRA exercise to update product information following European paediatric work-sharing procedures
Following our announcement on 18 November 2008, requests have now been sent to marketing authorisation (MA) holders for products containing simvastatin where product information has not already been updated. Further information is available in the Medicines for Children section of our website.
MHRA excerise to update summary of product characteristics (SmPCs) following EU paediatric work-sharing procedures
26 November 2009: MHRA exercise to update product information following European paediatric work-sharing procedures
Following our announcement on 18 November 2008, requests have now been sent to marketing authorisation (MA) holders for products containing Isotretinoin where product information has not already been updated. Further information is available in the Medicines for Children section of our website.
MHRA excerise to update summary of product characteristics (SmPCs) following EU paediatric work-sharing procedures
17 August 2009: MHRA exercise to update product information following European paediatric work-sharing procedures
Following our announcement on 18 November 2008, requests have now been sent to marketing authorisation (MA) holders for products containing salmon calcitonin and ranitidine where product information has not already been updated. Further information is available on our 'Medicines for children' web-pages:
MHRA excerise to update summary of product characteristics (SmPCs) following EU paediatric work-sharing procedures
28 July 2009: MHRA exercise to update product information following European paediatric work-sharing procedures
Following our announcement on 18 November 2008, requests have now been sent to marketing authorisation (MA) holders for products containing fluvastatin where product information has not already been updated. Further information is available below:
16 June 2009: Including the product name when submitting information on paediatric studies in accordance with the Paediatric Regulation
Since the introduction of the European Paediatric Regulation in 2007, marketing authorisation (MA) holders are required to submit paediatric studies completed since the date of entry into force (26 January 2007) to the competent authority within six months (Article 46). Member States, through CMD(h) (Coordination Group for Mutual Recognition and Decentralised Procedures (external link)) have agreed a procedure whereby MA holders initially notify competent authorities of the study via e-mail. Templates for the cover sheet and line-listing available on the CMD(h) website for this purpose. In the UK, such notifications should be sent to paediatricstudies@mhra.gsi.gov.uk as described on our website:
Requirements for submission of paediatric information required by EU Paediatric Regulation
MA holders are requested to make sure that they include the name of their product in the subject line of such emails so that they can be readily identified for future use.
28 May 2009: MHRA exercise to update product information following European paediatric work-sharing procedures
Following our announcement on 18 November 2008, requests have now been sent to marketing authorisation (MA) holders for products containing i) fosinopril and ii) sumatriptan where product information has not already been updated. Further information is available below:
MHRA excerise to update summary of product characteristics (SmPCs) following EU paediatric work-sharing procedures
2008
27 March 2008: MHRA exercise to update product information following European paediatric work-sharing procedures
Following our announcement on 18 November 2008, requests have now been sent to MA holders for products containing i) carboplatin and ii) budesonide where product information has not already been updated.
18 February 2008: Revised guidance on undertaking the compliance check
Marketing authorisation holders are reminded that the obligation for applications for new indications (including paediatric indications), new pharmaceutical forms and new routes of administration to comply with a Paediatric Investigation Plan (PIP) came into force on 26 January 2009. This requirement arises from Article 8 of the EU Paediatric Regulation.
Revised guidance on undertaking the compliance check
23 December 2008: Results of consultation on amendments to the Medicines for Human Use (Marketing Authorisations etc) Regulations 1994
We have published the results of MLX 347 which sought your views on proposals to introduce measures in the UK to enforce the obligations set out in Regulation (EC) No. 1901/2006 (the Paediatric Regulation).
11 December 2008: MHRA exercise to update product information following European paediatric work-sharing procedures
Requests have now been sent to MA holders for products containing gemcitabine where product information has not already been updated.
18 November 2008: MHRA announces an exercise to update Summaries of Product Characteristics (SmPCs) to include paediatric information following completion of European work-sharing procedures
We are initiating an exercise to include paediatric information in all marketing authorisations.
29 July 2008: Guidance on the MHRA’s handling of the requirement in the Paediatric Regulation to undertake a ‘compliance check’ during validation
We have published guidance to companies on how we intend to handle the impact of the requirements of the Paediatric Regulation on the validation of applications for marketing authorisations:
