| Pharmacovigilance rules and regulations are | | | | stage to involve a pharmacovigilance services |
| understandably complex, aimed at ensuring there is | | | | company to ensure the process is properly |
| always ongoing good quality reporting and monitoring | | | | administrated and staff understand fully what is |
| of pharmaceutical products. There's no substitute for | | | | required at all stages to avoid mistakes. |
| the professional advice of a pharmacovigilance | | | | About The Mutual Recognition Procedure |
| services company, but this article provides a brief | | | | Here this refers to cases where a marketing |
| guide to some of the key regulations and guidelines | | | | authorisation has been authorised by one EU country |
| for products marketed in the EU. This guide can be a | | | | and it is essentially copied by all other EU countries. |
| useful adjunct to professional advice to allow better | | | | There is the 'Reference Member State', where the |
| pharmacovigilance work liaison with related teams in | | | | marketing authorisation is granted, and the other |
| understanding of how the Centralised Procedure, | | | | countries, referred to as the 'Concerned Member |
| Mutual Recognition Procedure and Decentralised | | | | States'. An application under the Mutual Recognition |
| Procedure operate in the EU. | | | | Procedure incurs a 90 day period during which the |
| The Three Routes for Pharmaceutical Product | | | | 'Concerned Member States' accept the product as |
| Registration | | | | far as Marketing Authorisations are concerned or |
| Pharmaceutical products which are to be marketed in | | | | raise considerations about the product. If the |
| one or more member states of the EU must be | | | | application is successful, a marketing authorisation is |
| subjected to one of three procedures to gain the | | | | given which is an identical summary of product |
| correct Marketing Authorisations status: | | | | characteristics to that of the original marketing |
| "Centralised Procedure" - Regulation (EC) No 726 | | | | authorisation in the 'Reference Member State'. |
| 2004 | | | | Sometimes, the process will not automatically |
| "Mutual Recognition Procedure" | | | | succeed. EU countries may raise objections and in the |
| "Decentralised Procedure" - Directive 2001/83/EC. | | | | intervening time, the original marketing Authorisation |
| There are also certain extra-national authorisations | | | | will simply not be recognised by them. The next |
| which allow products to be marketed in some single | | | | stage is then referral to the EMEA, where the |
| EU member states. This means products may be | | | | matters are formally debated, involving all concerned |
| regulated under separate authorisation in two or | | | | parties. If this step does not resolve the issues, there |
| more individual EU countries. The Mutual Recognition | | | | then will be recourse to binding arbitration. |
| Procedure allows for application for a national | | | | This is another stage at which professional advice |
| authorisation. The regulatory body in the country in | | | | from an experienced relatedpharmacovigilance |
| which the original national authorisation was obtained | | | | servicesteam is obviously going to be of paramount |
| is deemed responsible for product monitoring and | | | | importance to guide the applicant throughout the |
| safety assessment. | | | | process. |
| About The Centralised Procedure | | | | About The Decentralised Procedure |
| This is the administrative responsibility of the EMEA. | | | | When no marketing authorisation has been issued in |
| A single application for marketing authorisation for all | | | | any EU country, an identical dossier is submitted to |
| the countries in the European Union (and the | | | | every EU country in which a marketing authorisation |
| European Economic Area, meaning all EU countries, | | | | is desired. The applying company can nominate which |
| Iceland, Norway and Liechtenstein) is made. If | | | | country becomes the 'Reference Member State'. The |
| applications are approved, at the point they enter the | | | | company must compile a preliminary report within a |
| market then all products become the responsibility of | | | | timeframe of 120 days and distribute it to |
| The European Commission instead. | | | | appropriate personnel in regulatory agencies of all the |
| This option applies for all new or novel pharmaceutical | | | | EU countries concerned. Those countries are then |
| products and stands as the only route at this time | | | | allowed to approve or raise objections. In the case |
| for any biotechnology medicines. It's also the route | | | | of objections, there is a facilitation process which is |
| for any product which contains novel substances | | | | entered into to try to resolve the problems. A |
| which have the intended purpose of modifying | | | | further step should facilitation not proved expedient |
| serious disease. | | | | is again, arbitration. |
| The regulatory agency of one EU country is charged | | | | Throughout this regulatory process, the input of the |
| with becoming the Rapporteur, who completes the | | | | applicant's pharmacovigilance work team is vital to |
| initial assessments required for a Marketing | | | | ensure that the process continues smoothly. The |
| Authorisation. Their Rapporteur will undertake initial | | | | involvement of many countries requires a truly |
| assessments which are necessary for the application | | | | international level of expertise and applicants are |
| for a Marketing Authorisation. In addition, as a | | | | advised to partner with experienced |
| double-checking system, there will be the | | | | pharmacovigilance companies. |
| appointment of a Co-Rapporteur, a second agency | | | | Understanding these three basic regulatory pathways |
| to oversee things, from a second EU country. | | | | can be useful when working with an in-house or |
| Between the two agencies, the safety assessment | | | | external pharmacovigilance services team. From this |
| and monitoring are directed in a controlled manner to | | | | background reading, it should be easier to begin |
| allow the product to be introduced onto the market. | | | | discussions around the legal requirements of product |
| They will also hold responsibility for the continuing | | | | registration in the EU. In every eventuality, there is |
| pharmacovigilance work during the time the product | | | | no better advice than that of experienced |
| will be on sale after its introduction. | | | | international pharmacovigilance workconsultants. |
| Application for a Marketing Authorisation is a key | | | | |