REGULATORY LABELING PROCESS & REQUIREMENTS IN DUBAI

Regulatory Labeling

Regulatory labeling as well as artwork jobs are worried about the labeling and packaging of pharmaceutical products as per the regulation; essentially the information printed on the outward packaging also the inner leaflet, which contains essential safety information as well as any adverse effects. The artwork aspect of these roles guarantees that the packaging adheres to the organization’s brand rules. Depending on the size and type of the organization, this could be inside the labeling expert’s responsibilities or done by a dedicated artwork team.

Typical everyday responsibilities of a regulatory artwork and labeling role in the pharmaceutical industry will be authoring PILs (patient information leaflets) and SmPCs (summary of product characteristics. They are additionally responsible to update the label information as per the health authorities, reviewing the documents as well as updating the organization’s core datasheet, that contains information on each product developed by the organization.

What are Product Labeling and its importance?

Whenever one decides to manufacture a product, you need to communicate the value of the product to the clients. There are many ways but one of the ways to do that is using the product labeling. Product labeling has become a method for communication between the consumer and the brand. Product labeling has essential information that is printed on the packaging of the product.

What is Product Labelling?

Product labeling is a part of the product packaging. Labeling is the information that is written on the packages. These written labels that are on the package cover essential information that needs to be communicated to the client. It is very important to know that product labeling differs from the packaging. The product may have the brand colors, logos, material, and the shape of the package, etc. The product is the written/informational part. All these labeling necessities come from the regulatory body. There are various regulatory bodies for all the products.
Here is an example – A food product like Maggi noodles may have the ingredients of the products just as the instructions on how to make the illustrated and written on the package.
Product labeling can be as less as simply a couple of lines on the back of the product. Or it can be as much as the entire back end of the product being complete of written information.
If you pick any of the shampoos, you will see the back of the product full of information about the ingredients, manufacturing location, ways to apply, customer service, safety instructions, etc
Hence, any new product in the market needs to adhere to these labeling and packaging guidelines of their country’s regulatory bodies.
1. Brand & Product Identity

The label which is on the product is the primary product identity. The product name and the brand itself is considered as a major aspect of the product labeling and these product labels form the brand identity. Besides, it may be a lawful requirement to publish the parent brand alongside the sub-brand.

2. Grand and Type

Each Sunsilk shampoo has various types. Other than changing the packaging and design style of the product, they additionally change the label on the shampoo. Some of them shall say that the shampoo is an Anti-dandruff shampoo though the other will say smooth silk. Accordingly, product labeling can be used to understand the difference between the different types and grades of the product.

3. Requirements by law

As above mentioned, various labeling requirements may be specified by a regulatory body. Some of them that are common include the following

  • Ingredients
  • Manufacturing plant
  • Batch number
  • Expiry date
  • MRP
  • Safety instructions
Therefore, the company needs to consider all the lawful requirements before deciding on the product labeling.
4. Description:
By law, a product would not be required to print usage instructions on the packaging of the product. A few products use a manual for the communication on the same while others imbibe usage guidelines on the packaging itself.

If you require any assistance regarding the regulatory labeling, feel free to contact us on +971562181007 or drop a mail to info@msz.ae.Our professional experts are 24/7 available to assist you.