What is a Type Ia variation?
A minor change to a marketing authorisation that has a minimal or no impact on the quality, safety or efficacy of the medicine and does not require prior approval before implementation by the marketing authorisation holder.
What is a Type II variation?
A major change to a marketing authorisation that may have a significant impact on the quality, safety or efficacy of a medicine, but does not involve a change to the active substance, its strength or the route of administration.
What type of variations can be grouped?
1. What types of variations can be grouped? Article 7.2(a) of the Variations Regulation sets out the possibility for an MAH to group several type-IA and -IAIN variations under a single notification to the same relevant authority: Several type-IA or -IAIN affecting one medicinal product.
What is CMDh?
The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh), was set up in Directive 2004/27/ EC for the examination of any question relating to marketing authorisations of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the …
How long does a type II variation take?
The majority of type II variation procedures following a 30-day timetable (e.g. urgent safety issues) will most commonly follow the monthly start timetable. This is because they are likely to require Commission Decision within two months from CHMP Opinion and discussion during the CHMP plenary meeting.
What occurs during a Type Ia supernova?
If the white dwarf grows to over 1.44 times the mass of the Sun, the electrons are no longer strong enough to prevent the star from collapsing. At this point, the star explodes as a type Ia supernova. This mass limit is called the Chandrasekhar limit. During this type of explosion, the star is completely destroyed.
What is a type 1B variation?
A Type 1B variation is a minor change to a marketing authorisation. You can find out more about the details of this kind of change in the annex of the European guidance. PIQU assesses hundreds of Type 1B variations each year.
How long does a type 1B variation take?
For type-IB variations affecting the annexes to the Commission decision, the Commission decision will generally be updated within one year, unless the type-IB variation concerns any of the changes listed in Article 23.1a(a), for which the Commission decision will be updated within two months.
What is an RFI MHRA?
Any issues arising during the first phase will be raised with applicants in a “letter requesting further information” (RFI letter). These issues should be addressed within the clock off period.
What is MAA submission?
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
What is Psusa?
The PSUSA is a safety report required by the European Medicines Agency (EMA) for all human medicines from marketing authorisation holders. It includes information on the product’s safety profile, including any new safety concerns that have arisen since the product was first authorized.
What is a Type 1a supernovae defined as?
A Type Ia supernova (read: “type one-A”) is a type of supernova that occurs in binary systems (two stars orbiting one another) in which one of the stars is a white dwarf. The other star can be anything from a giant star to an even smaller white dwarf.
Why are type Ia supernovae so important as standard candles?
Since type Ia supernovae have a known brightness they can be used as standard candles to determine the distance to a galaxy once the stretch-factor is accounted for.
How long does a type 1b variation take?
What is a safety variation?
What is a Safety Variation? Summary of Product Characteristics and Package Leaflets (SmPCs/ PLs) are a key part of the MA of all medicines, and the basis of information for healthcare professionals on how to use a medicine safely and effectively.
How long does it take to get MHRA approval?
Processing times: new applications typically take 90 working days to process. variations where no inspection is required: 30 working days – variations where an inspection is required: 90 working days.
Is Maa same as NDA?
The application for marketing authorization is called New Drug Application (NDA) in the USA or Marketing Authorization Application (MAA) in the European Union. So, both NDA and MAA is application filed to obtain the marketing permission. Upon receiving the approval, medicine can be launched in market.
What are the 4 types of procedures for approval of drug in EU?
EU establishes 4 different drug approval processes: 1) Centralized Procedure 2) Decentralized Procedure 3) National Procedure 4) Mutual Recognition Procedure.
- The Basic Regulation.
- Investigational New Drug Application.
What is PSUR and DSUR?
The Development Safety Update Report (DSUR) is used for drugs still under development to assess risk to the subjects enrolled in the study, while the Periodic Safety Update Report (PSUR) is used for drugs already on the market to assess long-term safety.
What is the difference between Pbrer and PSUR?
Periodic Safety Update Reports (PSURs)/Periodic Benefit-risk Evaluation Reports (PBRER) Periodic safety update report (PSUR) provides a periodic and comprehensive assessment of the worldwide safety data of a marketed drug.