Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 71

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 71
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 countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. Some countries have a separate decision-making process in addition to whether the government or state insurers will reimburse the price for the product. The requirements governing drug pricing vary widely from country to country. For example:

| • | in the EU, member states can restrict the range of medicinal products for which their national health insurance systems provide reimbursement and, in most EU countries, the prices of medicinal products for human use must be approved by 
 national health authorities, before they may be supplied;                                                                                                                                                                                   |

| • | a common criterion relied upon by almost all EU Member States for pricing decisions is international reference pricing (the methodology and weight to be attached varies between countries), whereas in the UK, international reference 
 pricing is not a criterion relied upon formally for pricing decisions;                                                                                                                                                                  |

| • | in the UK and many EU member states, prices of branded medicines must be notified or approved prior to product launch; |

37 Table of Contents

| • | reimbursement decisions in EU/European Economic Area, or EEA, and the UK are typically based on various forms of health technology assessment, including cost effectiveness determinations. From 2025, the EU’s Health Technology Assessment  
 Regulation (Regulation (EU) 2021/2282), or HTA Regulation, will start to come into effect providing for a common assessment of clinical effectiveness to be taken into account by national reimbursement authorities across EU/EEA. This will 
 not have direct effect in the UK, but may in practice be influential; and                                                                                                                                                                     |

| • | additionally public procurement tenders are widely used for purchasing of medicinal products by hospitals. |

Even if we obtain approval of any of our product candidates in the United States or Europe, we may never obtain approval or commercialize such products in other countries, which would limit our ability to realize their full market potential. In order to market any products in the United States or EU, we must establish and comply with numerous and varying regulatory requirements regarding safety and efficacy. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval procedures vary among countries and can involve additional product testing and validation and additional administrative review periods. Seeking foreign regulatory approvals outside of where our clinical trials currently have been conducted could result in significant delays, difficulties and costs for us and may require additional nonclinical studies or clinical trials which would be costly and