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Prepared By: Dhaval J.Sankaliya M.Pharm. Sem. II (Pharmaceutics) Department of Pharmaceutical sciences, Saurashtra University,Rajkot . 1


Contents: What is MHRA? Functions of MHRA What is Marketing authorization? Marketing authorization for what? Who can apply? Procedures for applying Types of applications Parallel importing authorization How to submit an application? Fast-tracking the applications Renewal and cancellation of license 2

What is MHRA?:

The MHRA was set up in April 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). The MHRA is responsible for ensuring that medicines and medical devices work, and are acceptably safe . What is MHRA? 3 The M edicines and H ealthcare products R egulatory A gency (MHRA) is an executive agency of the Department of Health of United Kingdom .

Functions of MHRA:

Clinical trials The MHRA has no interest in these early stages of drug development. MHRA comes in play when the company wants to start clinical trials in patients . Functions of MHRA 4

Functions of MHRA:

Functions of MHRA 5 Note :MHRA does not regulate dietary supplements, veterinary products and cosmetics.

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Before any medicine can be used to treat people in the UK , a marketing authorisation , from the MHRA is required. The MHRA operates a system of licensing before the marketing of medicines. Medicines which meet the standards of safety, quality and efficacy are granted a marketing authorisation (previously a product licence), which is normally necessary before they can be prescribed or sold. What is Marketing authorization? 6

Marketing authorization for What?:

Marketing authorization for What? 7 New biological or chemical compounds. Different brands of existing medicines. Generics (identical but cheaper versions of existing branded medicines) New forms of existing medicines, such as syrups, patches, or injections. New uses for existing medicines, such as different patient groups or different conditions.

Process of licensing:

Process of licensing 8

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Applications are generally submitted by the pharmaceutical industry, but anyone with the necessary supporting data may apply for a licence. Who can apply? 9

Types of procedures:

Types of procedures 10 European Union (EU) European Medicines Agency (EMEA)

Types of procedures:

Types of procedures 11 A. Centralised procedure In the European Union (EU), a company may submit a single application to the European Medicines Agency (EMEA) for a marketing authorisation (licence) that is valid simultaneously in all EU Member States.


Cont. . 12 B. National procedure Each EU Member State has its own procedures for the authorisation of medicines that fall outside the scope of the centralised procedure. Applicants must submit an application to the competent authority of the Member State. For eg.In the UK, this is the MHRA.


Cont.. 13 C. Decentralised procedure Using the decentralised procedure, companies may apply for simultaneous authorisation in more than one EU country of products that have not yet been authorised in any EU country and that do not fall within the mandatory scope of the centralised procedure.


Cont.. 14 D.Mutual recognition procedure In the mutual recognition procedure, a medicine is first authorised in one EU Member State, in accordance with the national procedures of that country. Following this, further marketing authorisations can be sought from other EU countries in a procedure whereby the countries concerned agree to recognise the validity of the original, national marketing authorisation .

Types of applications:

Types of applications 15 1) Full applications Applications for new active substances are described as 'full applications'. 2) Abridged applications Applications for medicines containing existing active substances are described as 'abbreviated’ or ‘abridged applications’. Existing drugs with new forms, routes and indications Sometimes, although the drug is the same, the new product has a different strength or pharmaceutical form or is used by a different route or for different clinical uses .


Cont.. 16 Existing drugs in new combinations New combinations of existing drugs may also be proposed though they may need a full data package to support them. 'Well-established' drugs and products The new product may include a drug substance which has such a well-established medicinal use and an acceptable level of safety that the applicant company can submit published data to support the safety and efficacy aspects of their application. Examples here may include some over-the-counter (OTC) remedies.


Cont.. 17 3) Informed consent and change of ownership applications For commercial reasons companies may want to take over or duplicate a product licence held by another company. Where the first company agrees to this 'informed consent' approach, the second company can get an exact copy licence commonly known as a 'piggy-back' licence. Alternatively, where the ownership of the company changes hands and the new owners need to take over the old product licences. These applications are called 'change of ownership' applications.

Parallel importing authorization:

Parallel importing authorization 18 The UK Parallel Import Licensing Scheme allows medicinal products authorised in other EU Member States to be marketed in the UK, provided the imported products have no therapeutic difference from the equivalent UK products.

Types of parallel import:

Types of parallel import 19 Simple application This category will apply when the UK product and the product to be imported from a Member state are made under licence from the same licensor. This is the traditional ‘common origin’ criterion. Standard application: This category will apply when the UK and imported products do not share a common origin (as defined above) and the application is not ‘Complex’ (see below).


Cont.. 20 Complex application: This category will apply when the UK and imported products do not share a common origin (as defined above) and: the imported product contains a new excipient . (b) the imported product contains an active ingredient made by a different route from that used in the UK product (c) the imported product is eg . a controlled release preparation a metered dose inhaler a powder for inhalation


Cont.. 21 (d) the imported product is a sterile product which is sterilised in a different way from the UK product (e) the imported product is a sterile product in which the container is made from a different material to the container of the UK product (h) the manufacturer of the active ingredient contained in the imported product is different from the manufacturer of the active ingredient contained in the UK product.

How to submit application?:

How to submit application? 22 All applications must follow the common technical dossier  (CTD) format which has been a requirement since 2003. The preferred format for new marketing authorisation (MA) applications is the electronic Common Technical Dossier (eCTD). eCTD applications must be created according to the current specifications. However, MHRA accept that many companies are not yet ready to submit applications in eCTD format. Therefore, it accepts applications in PDF-only format also.

Fast tracking of application:

Fast tracking of application 23 Under certain circumstances MHRA facilitates fast tracking of MA applications. These circumstances are mainly categorized in two headings .

Fast tracking of application:

Fast tracking of application 24 Major therapeutic breakthrough Disease categories for which fast tracking of applications may be applicable: Chronic, debilitating diseases for which available treatments are ineffective or otherwise inadequate. Severe or life-threatening diseases for which available treatments are ineffective or otherwise inadequate. The emergence in a disease with wide-spread resistance to treatment with currently available therapeutic agents. The emergence of a new disease entity which has severe or life-threatening effects and for which currently available treatments are ineffective or otherwise

Fast tracking of application:

Fast tracking of application 25 For shortfall of medicines MHRA facilitates fast tracking when there is shortage of the essential or life saving medicines to avoid harm to public health. In this case of scarcity of medicines MHRA communicates with Department of Health and verifies the shortage. Note: For both the above situations, a decision to fast track an application would mean that the assessment of the application is commenced out of turn, ahead of its order in the sequence of submitted applications. The documentation for such application should be consistent with legal requirements and guidelines relating to applications for marketing authorisations .

Renewal of license:

Renewal of license 26 New Marketing authorisations (MAs) are valid for five years and then may be renewed on the basis of a re-evaluation of the risk-benefit balance. Once renewed, the marketing authorisation will be valid for an unlimited period. Applications for renewal should be submitted at least six months before expiry.

Renewal of license:

Renewal of license 27

Cancellation of license:

Cancellation of license 28 If MAs holder does not file an application for renewal within specified time, MAs expires automatically. If the MAs holder does not wish to renew the licence, a letter should be sent indicating the cancellation to: Administrative Support Team Medicines and Healthcare products Regulatory Agency (MHRA). MHRA has authority to cancel license of product if it affects public health.

Marketing authorizations granted in January 2010. :

Marketing authorizations granted in January 2010. 29 Sr. no. Grant date MAs holder Licensed name 1 22/01/2010 Orchid Europe limited Modafinil 100 mg tablets 2 20/01/2010 Apsla limited Finasteride 5 mg film-coated tablets 3 14/01/2010 Reckitt benckiser (uk) limited Dettol med 4.8% w/w concentrate for cutaneous solution 4 11/01/2010 Focus pharmaceuticals limited Clindamycin 150mg/ml solution for injection or infusion 5 12/01/2010 Sandoz limited Ondansetron 4 mg film-coated tablets

References :

References 30 1)

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Thank you 31

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