Transfer of a manufacturing licence

This guidance is for Australian manufacturers who wish to transfer a manufacturing licence to another entity. This can happen because of:

• sale of a business
• other reasons

Acceptable reasons for transferring a licence are outlined in Regulation 22 (1), (2), (3) and (4), Therapeutic Goods Regulations 1990.

When a licence is transferred

If a licence is transferred, it is to be transferred as a whole. There is no provision for a partial transfer.

If the acquirer does not want to continue to perform all manufacturing steps on the current licence, then they need to make a variation application, after the licence has been transferred.

The licence remains in effect, as though it had been granted to the holder, in the new holder's name, from the date that the transfer takes place. Therefore, the 'acquirer' is taken to be the licence holder from that date and:

• can manufacture products as stated on the licence
• is required to abide by the terms and conditions of a licence holder of a manufacturing licence.

Please refer to Regulation 22, Therapeutic Goods Regulations 1990. You are encouraged to seek independent legal advice if necessary.

Sale of a business

A manufacturing licence can be transferred, under Regulation 22(4), Therapeutic Goods Regulations 1990:

• If a manufacturer is bought by another company and the sale of the business includes the sale of the manufacturing licence
• OR
• if there is a change in ownership of a business relating to the manufacture, distribution or sale of a therapeutic good (for example, by sale of shares) and this change of ownership includes transfer of the manufacturing licence held by that business owner

If the licence is not acquired as part of the disposal of the business, then a new licence would need to be sought by the company acquiring the business before the manufacture could take place.

If:

1. a person agrees to dispose of a business relating to the manufacture, distribution or sale of therapeutic goods; and

2. it is agreed that the disposal of that business is to include a transfer of a licence held by that person;

   then:

3. the person who acquires that business is taken to be the holder of the licence; and
4. that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.

The acquirer of the business will need to notify us by emailing the Manufacturing Quality Branch) within 3 months of acquiring the business.

This notification must be supported by suitable evidence:

• A letter from the Chief Executive Officer (CEO)/Managing Director (MD) from 'the seller' indicating that the business is being sold, including the manufacturing licence to 'the acquirer'
• A letter from the CEO/MD from 'the acquirer' indicating that 'the acquirer' has purchased the business, including the manufacturing licence transfer
• A sales agreement, or other suitable documents, proving the transaction has taken place, which also details the date the transfer took place

The 'acquirer' also needs to inform TGA if there are any significant changes to the licensed facility, e.g. changes to Quality Management System (QMS), licence nominee(s) (persons in control of production and quality control), operations, types of products, et cetera.

Other reasons for transfer

A manufacturing licence may also be transferred for the reasons outlined in regulation 22 (1), (2) or (3):

1. If a person who was the holder of a licence dies
2. If a person who is the holder of a licence becomes bankrupt
3. If a body corporate that is the holder of a licence is being wound up

In these circumstances, notify us by emailing the Manufacturing Quality Branch.

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