In the manufacturing industry, a factory may come across particular licensing requirements for production, using patented technology, or fulfilling regulatory requirements. In this case, according to every industry condition, a feasibility study will need to identify these licensing requirements, explain requirements for qualification, and show plans to acquire them. In general, there are two types of licensing requirements (e.g., for under-patent technology) that a factory may be required to get before it commences operation; the first set is that related technology license and the second set is for the regulatory licensing (e.g., like in the pharmaceutical industry). These licenses are critical for the factory’s success and may require additional time, effort, and costs.
Step-By-Step Process
- Evaluate your manufacturing industry and identify requirements for production and regulatory licenses.
- Where-ever there is a license requirement for producing a product or using technology, the study must identify this license scope, conditions, terms, costs, the way of acquiring (e.g., lease or buy or joint venture), and any other legal requirements.
- Set a plan showing the regulatory requirements and steps for qualifying the factory for them. For example, a pharmaceutical manufacturing facility must qualify for the GMP (Good Manufacturing Practice) licensing, registration of products, and obtain a business license in the country of origin.
- Estimate the costs for qualifying the business for production and regulatory licensing.
- Prepare the document as per the above outcomes, and share it with your team and experts.
Example
In the pharmaceutical industry, there are two groups of licensing; the first is regulatory, and the second is technology license. The pharma regulatory licenses are mandatory requirements imposed by the country of origin and include, for example, the site permit, operation permit, GMP license, product registration, and technical staff qualification. A patented technology holder imposes a use license and authorizes a licensee to use it in exchange for fees.
Useful Tips
- Check the website and other formal sources of information for the concerned regulatory authority in the country of origin for your business to obtain the regulatory licensing requirements.
- Consult experts and share discussions with your team and stakeholders.
- Carefully review any technology license and accept the one that can better support the company’s business plans.
Things To Avoid
- Avoid informal sources of information on obtaining regulatory licensing requirements.
- Don’t stick to one technology holder option but consider more options.
Final Note
This article is sourced from my new book- Your Guide For Preparing An Industrial Feasibility Study.
For more information about the book: https://growenterprise.co.uk/book-your-guide-for-preparing-an-industrial-feasibility-study/
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The author: Munther Al Dawood- Industrial Enterprise Expert
Grow Enterprise 