Diligence checklist · free tool

Healthcare M&A in South Africa: the regulatory exposure a standard review misses

In a regulated healthcare or life-sciences target, the exposure that moves the price sits in licences that may not transfer, study obligations that survive completion, and a quality, data and liability history a general diligence review does not test. Work through the 19 questions below before you sign.

0 of 19 reviewed

01 · Licences & authorisations

Are the SAHPRA establishment and manufacturing licences held by the target entity itself — and do they survive a change of control, or require fresh application?Do the product registrations and marketing authorisations sit with the target, or with a third party (a distributor or licensor)?Are any licences subject to conditions, suspensions, variations or pending renewals?For devices and diagnostics: are the establishment and product authorisations current under the applicable regime?

02 · Clinical & study obligations

Do any sponsor or clinical-trial obligations survive completion — ongoing studies, safety reporting, site or investigator commitments?Are the trial and CRO agreements assignable, and do their indemnity and insurance provisions continue after close?Are there institutional or investigator commitments that bind the target beyond the transaction?

03 · Quality, pharmacovigilance & liability

Is there a history of recalls, field-safety corrective actions or adverse SAHPRA findings?Are pharmacovigilance and safety-reporting obligations current, and is it clear who holds them?What open product-liability exposure exists, and how is it insured?

04 · Data & intellectual property

Who owns the study, clinical and patient data — and is its processing and cross-border transfer POPIA-compliant (consent, operator agreements)?Is the IP chain of title clean: background and foreground IP, licences in and out, and any university or funder rights?

05 · Contracts & change of control

Do the key distribution, supply, licensing and funding contracts carry change-of-control, consent or termination triggers?Do any development-finance or grant undertakings restrict the transaction (change of control, disposal, reporting)?

06 · Deal structure & approvals

Does the transaction cross the Competition Commission merger-control thresholds?Are there B-BBEE, exchange-control or foreign-investment considerations to structure around?Is regulatory risk expressly allocated in the warranties and indemnities, rather than left to implication?

07 · Day one after completion

Who holds the marketing authorisation, the manufacturing licence and the quality function on the first day after close?What governance and reporting obligations continue to funders or regulators post-completion?

General orientation only — not legal advice, and no attorney-client relationship arises from its use. A specific matter requires a written engagement.