① Do I need permission even if I want to import and sell products that are already being sold in other countries?
Even if a product is sold in another country, it is unclear whether it complies with Japanese standards, so in order to import and sell it in Japan, it will be necessary to go through the licensing procedures again in Japan.
② I will temporarily store the product at the distribution center of the manufacturer/seller, do I need permission?
For both marketing and marketing businesses and manufacturing businesses, the implementation status of the standards stipulated at the time of new application and the revision of the Pharmaceutical Affairs Law will be updated. Check to see if it has been done.
③Can I use my home as a business office?
If an office is attached to a private residence, it must be clearly separated from the permanent residence and unclean area. Please check with the relevant office in each prefecture for details.
2. manufacturing industry
① Is the inclusion of package inserts considered a manufacturing act?
It becomes a manufacturing act. In this case, since it is part of packaging, manufacturing registration is required at the place where the work is performed.
②What is the point of renewing the permit?
For both marketing and marketing businesses and manufacturing businesses, the implementation status of the standards stipulated at the time of new application and the revision of the Pharmaceutical Affairs Law will be updated. Check to see if it has been done.
③What is the point of changing permission?
This will be a change request. Apply by attaching the ``List of planned production items and documents related to the manufacturing process related to the change'' and ``Summary list of the structure and equipment of the manufacturing facility related to the category of permission you are trying to change'', etc.
④Is it okay for the president to become the general manufacturing and sales manager?
The person responsible for implementing the requirements as a manufacturing and sales business is the general manufacturing and sales manager (required: pharmacist).
If the president becomes the general manager of manufacturing and sales, the influence of sales considerations such as profitability will become stronger, and internal management may not work properly.
⑤Could you please introduce or arrange for someone who meets the requirements for a general manufacturing and sales manager position?
We do not provide job placement or referral services. Please use Hello Work, introduction companies, etc. to hire.
⑥ We import in vitro diagnostic drugs manufactured at overseas manufacturing facilities to Japan. Does the examination body go overseas for inspections?
The investigation for foreign manufacturer certification is, in principle, a written investigation. However, an on-site investigation may be conducted if the Agency deems it necessary. In the case of an on-site survey, the survey fee will vary, and the applicant will also be responsible for the travel expenses of the person in charge of the survey. The “applicant” is the foreign manufacturer.
⑦I have made a model change to my product, do I need to submit a notification?
In the case of a complete model change, it is necessary to apply for new approval or certification as a separate item.
⑧There is a template for the QMS/GVP manual, but is it okay to use it?
What is in the template are the minimum requirements. After meeting these requirements, it is necessary to adjust the content to suit the actual situation.
⑨What is the difference between ISO13485 and QMS ministerial ordinance?
ISO13485 is an international standard. The QMS ministerial ordinance is a quality control standard under Japanese law (Pharmaceuticals and Medical Devices Act). ISO is an international standard, so when exporting products overseas, obtaining ISO 13485 may be a condition.
⑩In addition to in vitro diagnostic drugs, we also handle other products. Can I store them in the same place?
There is no problem if the storage location is a warehouse, but in-vitro diagnostic drugs and other products must be stored separately in the warehouse.
⑪We have both manufacturing and sales licenses. There are some duplicate books such as inventory/output history, can I unify them into one?
Manufacturing and sales business and sales business are different businesses. Basically, accounts must be created separately.
3. About application
① Is the date of registration on the FD application form the date on which I was deemed as a registered business?
that's right.
② If the description in the manufacturing method column is “as before” due to an update, etc., is there a need to newly enter details when updating the description?
that's right.
③For items that do not require sterilization, is it okay to leave the manufacturing method column blank for the sterilized part?
that's right.
XNUMX. Other
①Do I need a sales license to exhibit at a showroom or exhibition?
Since the showroom is a business office, a sales permit is required even if there is no sales on the spot.
If the exhibition has a purpose such as sales, a permit is required, but if it is simply a display or exhibit and is managed by the manager of the office nearest the venue, a permit is not required.
② In what cases is succession of manufacturing and sales approval permitted?
1. In case of inheritance or merger with respect to the approval holder. 2. When an approval holder transfers all materials and information regarding the quality, efficacy, and safety of the inherited pharmaceuticals, etc., for the purpose of passing on the status through a contract with the successor.
③I heard that the department in charge of pharmaceutical affairs holds a seminar, but what kind of seminar is it?
We hold seminars on trends in pharmaceutical administration in each prefecture. Information is provided on the homepage of the relevant department. It seems that you may be able to consult with the officer in charge during the seminar, so we recommend that you participate after obtaining permission.
④I heard about a drug inspector certificate, but what is it?
A drug inspector certificate is a certificate required at customs clearance when importing products into Japan that have not yet been approved or certified in Japan. However, it cannot be imported for commercial purposes (selling or giving to others). You must apply for and obtain a drug supervisory certificate from the Health and Welfare Bureau in charge.
⑤Do I need a sales license if I am only communicating on the books and not actually handling the products?
Is required.
■For inquiries regarding approvals and approvals regarding in vitro diagnostic drugs, please contact Support Administrative Scrivener Corporation.
At Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act, from those newly entering the in vitro diagnostic drug industry to existing marketing distributors, manufacturers, and distributors. Masu. Applications for in vitro diagnostic drugs are highly specialized and can be said to be one of the fields in which there are few administrative scriveners who can handle them.
We provide legal services related to in vitro diagnostic drugs based on the know-how and track record that we can accumulate because we are administrative scriveners who handle applications and negotiations with administrative agencies on behalf of companies on a daily basis.
Our staff have experience applying in all prefectures across the country.
