Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 22920
2: Name of authorisation holder MORNINGSIDE PHARMACEUTICALS LIMITED
3: Address(es) of manufacturing site(s)

MORNINGSIDE PHARMACEUTICALS LIMITED, UNIT K, L, S, T2 AND U, 5 PAVILION WAY, CASTLE BUSINESS PARK, LOUGHBOROUGH, LE11 5GW, UNITED KINGDOM

MORNINGSIDE PHARMACEUTICALS LIMITED, SECOND FLOOR, BOSS COURT, 7 BARTON CLOSE, GROVE PARK, LEICESTER, LE19 1SJ, UNITED KINGDOM

4: Legally registered address of authorisation holder MORNINGSIDE PHARMACEUTICALS LIMITED, 5 PAVILION WAY, CASTLE BUSINESS PARK, LOUGHBOROUGH, LE11 5GW, UNITED KINGDOM
5: Scope of authorisation and dosage forms ANNEX 1 and/ or ANNEX 2
6: Legal Basis of authorisation
7: Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation Confidential
8: Authorisation Date 01/11/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

MORNINGSIDE PHARMACEUTICALS LIMITED, UNIT K, L, S, T2 AND U, 5 PAVILION WAY, CASTLE BUSINESS PARK, LOUGHBOROUGH, LE11 5GW, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.1 ] Sterile Products
        [ 2.2.1.1 ] Aseptically prepared
        [ 2.2.1.2 ] Terminally sterilised
    [ 2.2.2 ] Non-sterile products
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

MORNINGSIDE PHARMACEUTICALS LIMITED, SECOND FLOOR, BOSS COURT, 7 BARTON CLOSE, GROVE PARK, LEICESTER, LE19 1SJ, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.1 ] Sterile Products
        [ 2.2.1.1 ] Aseptically prepared
        [ 2.2.1.2 ] Terminally sterilised
    [ 2.2.2 ] Non-sterile products