• Contact us
  • Advertise with us
  • Login
Tashi Pharma
  • Home
  • Indian Pharma News
  • Global Pharma News
  • Guideline News
    • All
    • EDQM
    • EMA
    • European Commision
    • Health Canada
    • Medsafe
    • MHRA
    • SAHPRA
    • US FDA
    FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments

    FDA publishes Clinical Trial Guidances for Advancing Development of Cancer Treatments

    Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

    US FDA publishes guidance on Initiation of Voluntary Recalls

    EMA publishes Q & A for Bootstrap methodology for f2 similarity factor

    EMA publishes Q & A on Bootstrap methodology for f2 similarity factor

    US FDA publishes product-specific guidances to facilitate generic drug development

    US FDA publishes product-specific guidances to facilitate generic drug development

    Clinical Trials Regulation comes into effect in the EU

    New Clinical Trials Regulation comes into effect in the EU

    Reflection paper Forecasting demand for medicinal products in the EU_EEA

    EMA publishes reflection paper on forecasting demand for medicinal products in the EU/EEA

    Trending Tags

    • Pharma
    • EMA
    • MHRA
    • TGA
    • US FDA
  • Articles
  • Interview
  • Company Focus
  • Pharma Jobs
    • Quality
    • Regulatory Affairs
    • Production
    • Sales and Marketing
    • Clinical
    • bioanalytical
  • Webinar
No Result
View All Result
  • Home
  • Indian Pharma News
  • Global Pharma News
  • Guideline News
    • All
    • EDQM
    • EMA
    • European Commision
    • Health Canada
    • Medsafe
    • MHRA
    • SAHPRA
    • US FDA
    FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments

    FDA publishes Clinical Trial Guidances for Advancing Development of Cancer Treatments

    Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

    US FDA publishes guidance on Initiation of Voluntary Recalls

    EMA publishes Q & A for Bootstrap methodology for f2 similarity factor

    EMA publishes Q & A on Bootstrap methodology for f2 similarity factor

    US FDA publishes product-specific guidances to facilitate generic drug development

    US FDA publishes product-specific guidances to facilitate generic drug development

    Clinical Trials Regulation comes into effect in the EU

    New Clinical Trials Regulation comes into effect in the EU

    Reflection paper Forecasting demand for medicinal products in the EU_EEA

    EMA publishes reflection paper on forecasting demand for medicinal products in the EU/EEA

    Trending Tags

    • Pharma
    • EMA
    • MHRA
    • TGA
    • US FDA
  • Articles
  • Interview
  • Company Focus
  • Pharma Jobs
    • Quality
    • Regulatory Affairs
    • Production
    • Sales and Marketing
    • Clinical
    • bioanalytical
  • Webinar
No Result
View All Result
No Result
View All Result
Home Guideline News MHRA

MHRA publishes Guidance on Types of application (legal basis)

Appropriate legal basis for application must be selected when applied to MHRA for a marketing authorisation

PRN by PRN
March 30, 2021
in Guideline News, MHRA
106 1
0
MHRA Publishes GPvP inspection reports under the Freedom of Information Act

MHRA logo

69
SHARES
164
VIEWS

The appropriate legal basis will depend the type of application you are making. The legal bases are:

  • full application – Regulation 50 (previously Article 8(3) of Directive 2001/83/EC)
  • generic application – Regulation 51 (previously Article 10.1 of Directive 2001/83/EC)
  • hybrid application – Regulation 52 (previously Article 10.3 of Directive 2001/83/EC)
  • similar biological application – Regulation 53 (previously Article 10.4 of Directive 2001/83/EC)
  • well-established use application – Regulation 54 (previously Article 10a of Directive 2001/83/EC)
  • fixed-combination application – Regulation 55 (previously Article 10b of Directive 2001/83/EC)
  • informed consent application – Regulation 56 (previously Article 10c of Directive 2001/83/EC)
  • traditional herbal registrations – Regulation 125 & 126 (previously Article 16a of Directive 2001/83/EC)
  • certificate of homeopathic medicinal products (called Simplified Registration scheme) – Regulation 102 (previously Article 14(1) of Directive 2001/83/EC)
  • national homeopathic products (called the National Rules Scheme) – Regulation 50(6)(g) and Schedule 10 (previously Article 16(2) of Directive 2001/83/EC)

For details, please refer to below link

https://www.gov.uk/guidance/types-of-application-legal-basis?utm_medium=email&utm_campaign=govuk-notifications&utm_source=0478e257-91eb-4039-930b-962a8d7f9038&utm_content=immediately

 

Tags: MHRA
Previous Post

MHRA publishes guidance Electronic Application Form (eAF) and Cover Letter

Next Post

Incyte Announces the European Commission Approval of Pemazyre® (pemigatinib) as a Treatment for Locally Advanced or Metastatic Cholangiocarcinoma

PRN

PRN

Related Posts

FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments
Guideline News

FDA publishes Clinical Trial Guidances for Advancing Development of Cancer Treatments

by admin
March 5, 2022
Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C
Guideline News

US FDA publishes guidance on Initiation of Voluntary Recalls

by admin
March 5, 2022
EMA publishes Q & A for Bootstrap methodology for f2 similarity factor
EMA

EMA publishes Q & A on Bootstrap methodology for f2 similarity factor

by admin
February 25, 2022
US FDA publishes product-specific guidances to facilitate generic drug development
Guideline News

US FDA publishes product-specific guidances to facilitate generic drug development

by admin
February 20, 2022
Clinical Trials Regulation comes into effect in the EU
Guideline News

New Clinical Trials Regulation comes into effect in the EU

by admin
February 7, 2022
Next Post
Incyte Announces the European Commission Approval of Pemazyre® (pemigatinib) as a Treatment for Locally Advanced or Metastatic Cholangiocarcinoma

Incyte Announces the European Commission Approval of Pemazyre® (pemigatinib) as a Treatment for Locally Advanced or Metastatic Cholangiocarcinoma

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Recent News

Zydus to launch Oxemia

Zydus to launch Oxemia (Desidustat) a treatment for Anemia in patients with Chronic Kidney Disease (CKD)

March 7, 2022
FDA Urges Companies to be 'Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls

US FDA Urges Companies to be ’Recall Ready’ to Protect Public Health

March 6, 2022
FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments

FDA publishes Clinical Trial Guidances for Advancing Development of Cancer Treatments

March 5, 2022
Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

US FDA publishes guidance on Initiation of Voluntary Recalls

March 5, 2022
Kilitch Drugs Commences Rs. 100 Crore New Facility Expansion Plan

Kilitch Drugs Commences Rs. 100 Crore New Facility Expansion Plan

March 5, 2022

Browse by Category

  • Articles
  • Company Focus
  • EDQM
  • EMA
  • European Commision
  • Global Pharma News
  • Guideline News
  • Health Canada
  • Indian Pharma News
  • Interview
  • Medsafe
  • MHRA
  • SAHPRA
  • US FDA
  • Webinar

Browse by Tags

Abbott Alembic alkem Amgen Amneal AstraZeneca bayer biocon Biogen BioNTech Bristol Myers Squibb cipla covid Daiichi Sankyo drreddy Eli Lilly fda Gilead glenmark gsk Incyte Janssen Jubilant lupin MHRA Moderna Natco Novartis Novavax novo nordisk oncology Panacea Biotech Pfizer pharmacy Pharma News Pharmareg News Remdesivir roche sanofi Sun pharma Teva usfda Vaccine Viatris zydus

Contact us

Address:Pharma Reg News, First floor, Shop no.1 , Plot no 241,242, Near Fire station, GIDC, Ankleshwar, Gujarat - 393002.
Phone:+91 8511586232, +91 9029066605
Email:author@pharmaregnews.com

Browse by Tag

Abbott Alembic alkem Amgen Amneal AstraZeneca bayer biocon Biogen BioNTech Bristol Myers Squibb cipla covid Daiichi Sankyo drreddy Eli Lilly fda Gilead glenmark gsk Incyte Janssen Jubilant lupin MHRA Moderna Natco Novartis Novavax novo nordisk oncology Panacea Biotech Pfizer pharmacy Pharma News Pharmareg News Remdesivir roche sanofi Sun pharma Teva usfda Vaccine Viatris zydus

Advertise with us

© 2021 - Pharmaregnews.com. Developed by YESWEUS.

No Result
View All Result
  • Home
  • Indian Pharma News
  • Global Pharma News
  • Guideline News
    • EMA
    • MHRA
    • TGA
    • US FDA
  • Articles
  • Interview
  • Company Focus
  • Pharma Jobs
    • Quality
    • Regulatory Affairs
    • Production
    • Sales and Marketing
    • bioanalytical
    • Clinical
  • Webinar
  • Contact us
  • Advertise with us
  • Login

© 2021 - Pharmaregnews.com. Developed by YESWEUS.

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In
Are you sure want to unlock this post?
Unlock left : 0
Are you sure want to cancel subscription?