2. LITERATURE REVIEW
As the pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive, regulatory agencies are being established in various countries across the globe.
Regulatory agencies and organizations play a vital role to meet the requirements of legal procedures related to drug development process in a country.

3. LITERATURE REVIEW
In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing and labeling of pharmaceutical products.

4. MARKETIING AUTHORIZATION FOR HIGHLY QUALIFIED MEDICINES IN EUROPE.

5. AIM and OBJECTIVE
To facilitate the patients/consumers with high quality medicines which are assessed, qualified and approved by various regulatory bodies
To submit the dossier required for the drugs to be marketed through the CTD format
To mention the Blue-Box requirements within the countries of the European Union.

6. EXPERIMENT Global Scenario about the marketing of medicines
Rationale for entry into the Global Markets
Avenues for entry into other markets
Basics/Sources for the marketing authorization in the specified region
Country to country specifications on the labeling within the selected region during the marketing of the products

7. TYPES OF APPLICATONS
According to Article 8(3) of Directive 2001/83/EC;
According to Article 10 of Directive 2001/83/EC, relating to generic medicinal products and similar biological medicinal products;
According to Article 10a of Directive 2001/83/EC, relating to applications relying on well-established medicinal use supported by bibliographic literature;
According to Article 10b off Directive 2001/83/EC, relating to applications for new fixed combination products;
According to Article 10c of Directive 2001/83/EC, relating to informed consent from a marketing authorization holder for an authorized medicinal product.

8. STEPS INVOLVED IN OBTAINING EU MARKETING AUTHORIZATION
Submission of Eligibility Request
Notification of intention to submit an application
Appointment of Rapporteurs
Pre-Submission meeting
Submission of application
Scientific Evaluation
CHMP Scientific Opinion
EC decision on Marketing Authorization
Entry into Market

9. INTRODUCTION Centralized Procedure De-centralized Procedure
Marketing Authorization
Centralized Procedure
De-centralized Procedure
National Procedure
Mutual
Recognition
Procedure

10. EMEA and AUTHORIZATION PROCEDURE
In 1993 the European Medicines Agency(EMEA) was founded with the primary task of providing scientific advice of the highest possible quality to the Community Institutions on all matters relating to medicinal products for human and veterinary use.
EMEA's main task is to co-ordinate the scientific evaluation of the safety, efficacy and quality of medicinal products which undergo either procedure. All scientific questions arising in these procedures are dealt with by the EMEA.

11. PROCEDURES IN EU CENTRALIZED PROCEDURE
In the European Union (EU), a company may submit a single application to the European Medicines Agency (EMA) for a marketing authorization (license) that is valid simultaneously in all EU Member States, plus Iceland, Liechtenstein and Norway. This is called the centralized (or community) authorization procedure, and is mandatory for certain types of medicines and optional for others.

12. CENTRALIZED PROCEDURE
Day1 start of procedure
Day120 Assessment Report
Day215 In 20 languages SPC submission by applicant
Day 80 Preliminary Assessment Report
Day150 Issuance of joint Assessment Report
Day229 Approval
Day100 Comments for CHMP/EMEA
Day210 Adoption of CHMP opinion and Assessment Report

13. RULES OF PROCEDURE FOR STANDING COMMITTEE ON MEDICINAL PRODUCTS FOR HUMAN USE
CONVENING MEETING
AGENDA
DOCUMENTATION TO BE SENT TO MEMBERS OF THE COMMITTEE
OPINION OF THE COMMITTEE
REPRESENTATION
WORKING GROUPS
THIRD PARTIES AND EXPERTS
WRITTEN PROCEDURE
PROTECTION OF PERSONAL DATA

14. COMMUNITY REGISTER
The Community Register lists all medicinal products for human and veterinary use as well as orphan medicinal products that have received a marketing authorization through the centralized procedure.
The information provided in the Register can be accessed either by searching for the name of the product, the name of the active substance (INN) or the EU registration number.

15. COMMUNITY REGISTER
This information includes: the name of the medicinal product, the EU registration number, the name and address of the marketing authorization holder, the active substance, the international non-proprietary name, the ATC code, the therapeutic indication and the date of issue of the marketing authorization valid throughout the EU.
The Register also provides information on medicinal products for human and veterinary use adopted nationally for which a Commission decision was necessary.

16. PROCEDURES IN EU
NATIONAL PROCEDURE Each EU Member State has its own procedures for the authorization of medicines that fall outside the scope of the centralized procedure. Applicants must submit an application to the competent authority of the Member State. For example in the UK MHRA is the national competent authority.

17. PROCEDURES IN EU
DE-CENTRALIZED PROCEDURE Using the decentralized procedure, companies may apply for simultaneous authorization in more than one EU country of products that have not yet been authorized in any EU country and that do not fall within the mandatory scope of the centralized procedure.

18. DE-CENTRALIZED PROCEDURE
As the mutual recognition procedure, it is also based on recognition by national authorities of a first assessment performed by one member state. the difference lies in that it applies to medicinal products which have not received a marketing authorization at the time of application.

19. PROCEDURES IN EU
MUTUAL RECOGNITION PROCEDURE In the mutual recognition procedure, a medicine is first authorized in one EU Member State, in accordance with the national procedures of that country. Following this, further marketing authorizations can be sought from other EU countries in a procedure whereby the countries concerned agree to recognize the validity of the original, national marketing authorization.

20. MUTUAL RECOGNITION PROCEDURE
An application for mutual recognition may be addressed to one or more Member States. The applications submitted must be identical and all Member States must be notified of them.
As soon as one Member State decides to evaluate the medicinal product , it notifies this decision to other Member States , to whom applications have also been submitted.

21. COMMON TECHNICAL DOCUMENT

22. PRE-SUBMISSION MEETINGS
The pre-submission meeting will also allow identification of additional expertise to be involved at an earlier stage in the procedure.
The discussion during the pre-submission meeting is based on the information provided by the company, in writing and during the meeting. Scientific opinions expressed represent the personal views of the EMA participants and would not necessarily represent the final opinion of the CHMP.

23. PRE-SUBMISSION MEETINGS
Pre-submission meetings are an opportunity for companies to:
Introduce their proposed development program and receive feedback from coordinators and EMA staff.
Identify additional issues to be included in the request for scientific advice.
Obtain more detailed information concerning the procedure for obtaining scientific advice/protocol assistance.
Ask regulatory questions that are outside the scope of scientific advice (e.g. legal basis for submission, GCP/GLP/GMP-related questions, format of marketing-authorization application andCTD, etc.).

24. REFERRAL PROCEDURE
A referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines.
In a referral, European Medicines Agency is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the European Union (EU). The medicines, or the class of medicines, are ‘referred’ to the Agency so that it can make a recommendation for a harmonized position across the EU.

25. REFERRAL PROCEDURE Article 107i Procedures
Urgent action is necessary because of safety issue
Article 20 Procedure
For medicines by Centralized Procedure in case of manufacturing or safety issues
Article 31 Referrals
When interest of Community is involved relating to quality, safety, efficacy.
Article 29 Pediatrics
For new indication, pharmaceutical form or route of administration for use in children.
Article 13 Referrals
Medicines by MRP or DCP when disagreement between Member States on a variation (type II).
Article 29(4) Referrals
Disagreement between Member States by MRP or DCP on grounds of risk to public.
Article 30 Referrals
Lack of harmonization across EU

26. PUBLICATION OF INFORMATION ON REFERRALS
Information on referrals for human medicines is published under referrals. Users can search the database of referrals by medicine name and type of referral.
For safety-related referrals, it also includes information on how the public can submit data to be considered as part of the assessment and on whether a public hearing is taking place.

27. PRIODIC SAFETY UPDATE REPORTS
Periodic Safety Update Reports are documents intended to provide an evaluation of the risk benefit balance of a medicinal product. They shall be submitted by marketing authorization holders at defined time points during the post-authorization phase.
Once a medical product is registered in the EU, PSUR must be submitted, even if the product is not marketed.

28. PSUR
Time covered by PSUR 1
6 month 2 3 4 5
12 month 6 7
3 year
8, 9 etc.

29. BLUE BOX REQUIREMENTS
Each European state is permitted to require the following additional information on pharmaceutical product labels:
Name of the European state
Price of the pharmaceutical product
Reimbursement conditions of social security organizations
Legal status for supply to the patient, in accordance with Directive 2001/83/EC as amended
Product Identification and Authenticity (National Identification Number)
The preceding information should be printed on a label within a graphical blue box. The labels should be adhered to the side of the package. Text on the label should be written in the language of the European state which requires the additional information.

30. ELECTRONIC COMMON TECHNICAL DOCUMENT (e-CTD)
The e-CTD is the electronic equivalent to the CTD Regulatory Perspective “The e-CTD is defined as an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission”

31. ELECTRONIC COMMON TECHNICAL DOCUMENT (e-CTD)
Technical Perspective
Structured set of common folders structure containing PDFs and SAS files (statistical analysis software) on a CD/DVD
Can also be submitted through Agency web portals
Common structure for Modules 2 to 5
Agency specific requirements for Module 1

32. CONCLUSION
European Union is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, nation’s food supply, cosmetics, and products that emit radiation.
Advances the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.

33. CONCLUSION
The European Union assures continual improvement of processes and procedures, in accordance with recognized quality standards by adhering to high standards of professional and personal integrity. Also communicates in an open, transparent manner with all of the partners, stakeholders and colleagues as a result promoting the well-being, motivation and ongoing professional development of every member of the Agency.
The products authorized through the European Region reaches the market with high Quality of the standards and with good therapeutic use

34. REFERENCES http://ec.europa.eu/health/documents/eudralex/