Regulatory Pathways — Named Patient, Compassionate Use & Early Access

Poland Compassionate Use (Article 83 EMA)

EMA Article 83 compassionate use framework allowing access to unauthorised medicinal products for groups of patients with a chronically or seriously debilitating or life-threatening disease in Poland.

Form: National compassionate use form

15–45d medium30dRegulated under EU Directive 2001/83/EC

Portugal Compassionate Use (Article 83 EMA)

EMA Article 83 compassionate use framework allowing access to unauthorised medicinal products for groups of patients with a chronically or seriously debilitating or life-threatening disease in Portugal.

Form: National compassionate use form

15–45d medium30dRegulated under EU Directive 2001/83/EC

PPB Special Import Permit – Kenya

Kenya's Pharmacy and Poisons Board special import permit for unregistered medicines for named patients with serious medical conditions.

Form: PPB SIP Form

15–45d medium21dPharmacy and Poisons Act Cap 244

RDB Pharmacy Special Access – Rwanda

Rwanda Development Board pharmacy division special access program for unregistered medicines for patients with serious or life-threatening conditions.

Form: RDB Pharmacy Special Access Form

<15d fast14dRwanda Pharmacy Law

Romania Compassionate Use (Article 83 EMA)

EMA Article 83 compassionate use framework allowing access to unauthorised medicinal products for groups of patients with a chronically or seriously debilitating or life-threatening disease in Romania.

Form: National compassionate use form

15–45d medium30dRegulated under EU Directive 2001/83/EC

Roszdravnadzor Medical Use for Unregistered Drugs (Article 47) – Russia

Russian Federal Law No. 61-FZ on Medicines Circulation Article 47 allows use of unregistered medicinal products for individual patients with serious or life-threatening conditions under Ministry of Health permission.

Form: MOH Russia Application

15–45d medium30dFederal Law No. 61-FZ on Medicines Circulation

SAHPRA Section 21 Authorization – South Africa

SAHPRA Section 21 of the Medicines and Related Substances Act allows use of unregistered medicines when no suitable registered alternative exists, for named patients or in defined settings.

Form: SAHPRA Section 21 Application

15–45d medium30dMedicines Act Section 21

Saint Kitts and Nevis MOH Special Import Authorization

Saint Kitts and Nevis Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Saint Kitts and Nevis Special Import Form

15–45d medium45dRegulated

Saint Lucia MOH Special Import Authorization

Saint Lucia Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Saint Lucia Special Import Form

15–45d medium45dRegulated

Saint Vincent and the Grenadines MOH Special Import Authorization

Saint Vincent and the Grenadines Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Saint Vincent and the Grenadines Special Import Form

15–45d medium45dRegulated

Samoa MOH Special Import Authorization

Samoa Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Samoa Special Import Form

>45d slow60dRegulated

San Marino Special Import (via EMA framework)

San Marino special import authorization for unregistered medicines using the EMA/EU regulatory framework via neighboring EU country channels.

Form: San Marino Special Import Form

<15d fast14dVia EU/EMA regulatory framework

Sao Tome and Principe MOH Special Import Authorization

Sao Tome and Principe Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Sao Tome and Principe Special Import Form

>45d slow60dRegulated

Saudi Arabia Special Access Program (SAP)

SFDA's special access pathway for unlicensed medicines for individual patients.

Form: SAP Form

15–45d medium21dRegulated

Self-Treatment Import via KODC Exemption Recommendation – South Korea

Route for an individual patient to import a drug approved abroad but not in Korea. KODC reviews the application and issues an import-requirement exemption recommendation, which clears the consignment through customs. Processing takes 7 working days and there is no fee.

Form: Recommendation for Exemption from Import Requirements (수입요건 확인 면제대상 물품 중 의약품등의 추천 신청서)

<15d fast7dForeign Trade Act Arts. 11, 14; Enforcement Decree Art. 19; Foreign Trade Management Regulation Art. 19 (MFDS Notice 2020-111)

Senegal MOH Autorisation Exceptionnelle

Senegal Ministry of Health exceptional authorization for import of unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Senegal Exceptional Authorization Form

15–45d medium30dRegulated

Seychelles MOH Special Import Authorization

Seychelles Ministry of Health special import authorization for unregistered medicines for patients with serious medical conditions.

Form: Seychelles MOH Special Import Form

15–45d medium30dRegulated

SFDA Special Access Program (SAP) – Saudi Arabia

SFDA allows import of unregistered drugs for individual patients with serious unmet medical needs in Saudi Arabia, subject to physician request and SFDA approval.

Form: SFDA SAP Request Form

15–45d medium21dSFDA Drug Registration Rules

Sierra Leone MOH Special Import Authorization

Sierra Leone Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Sierra Leone Special Import Form

15–45d medium45dRegulated

Slovakia Compassionate Use (Article 83 EMA)

EMA Article 83 compassionate use framework allowing access to unauthorised medicinal products for groups of patients with a chronically or seriously debilitating or life-threatening disease in Slovakia.

Form: National compassionate use form

15–45d medium30dRegulated under EU Directive 2001/83/EC

Slovenia Compassionate Use (Article 83 EMA)

EMA Article 83 compassionate use framework allowing access to unauthorised medicinal products for groups of patients with a chronically or seriously debilitating or life-threatening disease in Slovenia.

Form: National compassionate use form

15–45d medium30dRegulated under EU Directive 2001/83/EC

SMCU Compassionate Use Program – Ukraine

Ukraine State Medicinal Centres compassionate use program allowing access to unregistered medicines for patients with serious or life-threatening conditions.

Form: SMCU Compassionate Use Application

15–45d medium21dUkraine Drug Regulation Law

Solomon Islands MOH Special Import Authorization

Solomon Islands Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Solomon Islands Special Import Form

>45d slow60dRegulated

Somalia MOH Special Import Authorization

Somalia Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Somalia Special Import Form

>45d slow60dRegulated

South Sudan MOH Special Import Authorization

South Sudan Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH South Sudan Special Import Form

>45d slow60dRegulated