Regulatory Affairs
In respect to managing product and sales tools localization, rules about consumer protection have to be kept. Every market has various regulations that need to be met before product can be sold. To keep it simply in this rather short explanation, Europe for example, requires for facial care products to file a notice with the applicable authorities, get the labeling compliant, and provide a safety assessment before these products can be sold.
Fortified foods are a little more complex. For example, in Europe again, the Union is currently rewriting the requirements for minimum and maximums of vitamins that can be packed into juices and foods (fortified). The product MUST be registered before it can be sold on the EU market place. It can be assumed that once the 2007 Fortification Revision is finished that in the near future the authorities will allow simple notifications again, as long as sampling of product will proof compliant.
Novel Foods of course, in the European Community (EC), any product in the nutritional supplement / liquid dietary supplement industry that contain food ingredients that after 1997 are new to the EC market, have to be approved in a lengthy process. This process is call Novel Food Registration (NFR). The current NFR rules and regulations are authored and published under EC Regulation 258/97. This process can take from about 2 to 4 or 5 years at times. Violating any rules prior to this sensitive application (and also rather costly), can lead to fines at the minimum, even to jail time, and worse, loss of marketing and sales rights.
Fortified foods are a little more complex. For example, in Europe again, the Union is currently rewriting the requirements for minimum and maximums of vitamins that can be packed into juices and foods (fortified). The product MUST be registered before it can be sold on the EU market place. It can be assumed that once the 2007 Fortification Revision is finished that in the near future the authorities will allow simple notifications again, as long as sampling of product will proof compliant.
Novel Foods of course, in the European Community (EC), any product in the nutritional supplement / liquid dietary supplement industry that contain food ingredients that after 1997 are new to the EC market, have to be approved in a lengthy process. This process is call Novel Food Registration (NFR). The current NFR rules and regulations are authored and published under EC Regulation 258/97. This process can take from about 2 to 4 or 5 years at times. Violating any rules prior to this sensitive application (and also rather costly), can lead to fines at the minimum, even to jail time, and worse, loss of marketing and sales rights.
About Labels:
The label is the product identification for the purpose to inform the consumers and protect them against misleading information. In most cases, because companies have a profit agenda, they would like to make the most of its product potential and permitted statements on labels and sales tools (marketing materials) may be a little stretched.I found that the most important traits for regulatory affairs activities are project management skills. Second, the next important skill to have is the ability to localize a product or sales tool to its market requirements, and be a marketing personality. This combination allows to focus on complying with regulations while giving the materials and products the maximum marketing exposure allowed by law.
Certainly, companies often are importing and selling their products even without a permit in a market. When caught, they hope to get a small punishment with a request to comply. But among competitors, in my experience, they hunt each other until they find a non-compliant product. This will quickly be reported to the authorities. And on goes the battle among them.
It is also a way to manage control over the vast many products on the market. For example, in the USA, at this time, bottled water is not regulated at all. The consumers are therefore not protected if someone where to get injured or hurt by it.
Final Word About Regulatory Affairs Management:
The work can become rather complex at times. This is because of cultural, legal, and language differences among those experts and professionals that provide outsourced services and also those stakeholders that work for the organization. In international organization it gets even more complex when the regulatory affairs manager has to include stakeholders in oversea's offices.Regulatory Affairs is not only about legalities and compliance of ingredients, content, claim statements, filing, registering, and submitting paper work and/or documents. It is also about localization. And most of all, it is also about project management skills and having people and relationship-building skills. This job required adaptability to change and the experience and skill to manage change.