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  • Ema Form 17 - Authorisation Of Persons To Act As Hazard Management Officer During An Emergency

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EMAForm 17: Authorisation of persons to act as Hazard Management Officer during an Emergency Situation under section 55 of the Emergency Management Act 2005 (WA). WESTERN AUSTRALIA Emergency Management.

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As per Regulation 726/2004, Article 831, Compassionate Use means to make unapproved medicinal products available to a group of patients that are suffering from a life-threatening, chronically or seriously debilitating disease, that otherwise cannot be adequately treated.

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relates to medicinal products for human use in mainly countries that are part of the European Union.

Article 46 requires marketing-authorisation holders to submit information on studies conducted in children of authorised medicines that have been completed since the Paediatric Regulation came into force on 26 January 2007 and are sponsored by the marketing-authorisation holder.

ing to Article 10(4) of Directive 2001/83/EC, when a biological medicinal product which is similar to a reference biological medicinal product does not meet the conditions in the definition of generic medicinal products, the results of appropriate pre-clinical tests and clinical trials must be provided.

The purpose of this Regulation is to lay down Community procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human and veterinary use, and to establish a European Medicines Agency (hereinafter referred to as 'the Agency').

Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

Article 83 of Regulation (EC) No 726/2004 on compassionate use is complementary to national legislations and provides an option to MS who wish to receive a CHMP opinion regarding the conditions for compassionate use of a specific medicinal product which falls within the scope of Article 83(1) and 83(2).

Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or ...

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232