PHARMACY AND MEDICINES REGULATORY AUTHORITY: SUBSIDIARY LEGISLATION
PHARMACY AND MEDICINES REGULATORY AUTHORITY (FEES AND FORMS) REGULATIONS
under s. 129
G.N. 9/2022
These Regulations may be cited as the Pharmacy and Medicines Regulatory Authority (Fees and Forms) Regulations.
The Authority shall charge the fees specified in the First Schedule, in respect of the matters correspondingly specified herein.
(1) The Authority shall charge a surcharge to any person who fails to pay retention fees as specified in the First Schedule.
(2) A person who fails to pay retention fees—
(a) within three months of the commencement of the Authority’s financial year, shall pay a surcharge of fifty per cent of the retention fees payable; and
(b) after three months of the commencement of the Authority’s financial year, shall pay a surcharge of one hundred per cent of the retention fees payable.
The forms set out in the Second Schedule shall be used for the purposes of the Act.
FIRST SCHEDULE
reg. 2
PRESCRIBED FEES
|
Matter |
Fees |
|
1. Registration fees for pharmacy personnel: on application for registration including issuance of a certificate— |
|
|
(a) pharmacist— |
|
|
(i) Malawian pharmacist, including internship |
50,000 00 |
|
(ii) non-Malawian pharmacist including vetting |
US$1,000 00 |
|
(iii) Malawian pharmacist re-examination fees, per subject |
25,000 00 |
|
(iv) non-Malawian pharmacist re-examination fees, per subject |
US$215 00 |
|
(v) non-Malawian volunteer pharmacist |
US$250 00 |
|
(b) pharmacy technologist— |
|
|
(i) Malawian technologist |
30,000 00 |
|
(ii) non-Malawian technologist, including vetting |
US$700 00 |
|
(iii) Malawian technologist re-examination fees, per subject |
10,000 00 |
|
(iv) non-Malawian technologist re-examination fees, per subject |
US$175 00 |
|
(c) pharmacy assistant— |
|
|
(i) Malawian pharmacy assistant |
20,000 00 |
|
(ii) non-Malawian pharmacy assistant, including vetting |
US$400 00 |
|
(iii) Malawian pharmacy assistant re-examination fees, per subject |
8,000 00 |
|
(iv) non-Malawian pharmacy assistant re-examination fees, per subject |
US$100 00 |
|
(d) medical representative— |
|
|
(i) Malawian medical representative |
150,000 00 |
|
(ii) non-Malawian medical representative |
US$700 00 |
|
2. Retention fees for pharmacy personnel— |
|
|
(a) pharmacist— |
|
|
(i) Malawian pharmacist |
30,000 00 |
|
(ii) non-Malawian pharmacist |
US$550 00 |
|
(iii) non-Malawian volunteer pharmacist |
US$250 00 |
|
(b) pharmacy technologist— |
|
|
(i) Malawian technologist |
20,000 00 |
|
(ii) non-Malawian technologist |
US$300 00 |
|
(c) pharmacy assistant— |
|
|
(i) Malawian pharmacy assistant |
15,000 00 |
|
(ii) non-Malawian pharmacy assistant |
US$300 00 |
|
(d) medical representatives— |
|
|
(i) Malawian medical representative |
75,000 00 |
|
(ii) non-Malawian medical representative |
US$300 00 |
|
3. Licencing of premises— |
|
|
(a) manufacturing licence— |
|
|
(i) inspection and processing for oral dosage forms (solids and liquids) |
1,500,000 00 |
|
(ii) inspection and processing for external preparations |
1,300,000 00 |
|
(iii) inspection and processing for sterile preparations |
1,700,000 00 |
|
(iv) inspection and processing for primary and secondary packaging |
1,000,000 00 |
|
(v) reinspection of premises, if previously failed |
*cost of travel |
|
(b) wholesale pharmacy licence— |
|
|
(i) inspection and processing |
760,000 00 |
|
(ii) reinspection fees of premises, if previously failed |
*cost of travel |
|
(c) retail pharmacy licence— |
|
|
(i) inspection and processing |
385,000 00 |
|
(ii) reinspection fees of premises, if previously failed |
*cost of travel |
|
(d) medicine store licence or veterinary shop licence— |
|
|
(i) inspection and processing |
200,000 00 |
|
(ii) reinspection fees of premises if previously failed |
*cost of travel |
|
(e) dispensing licence— |
|
|
(i) inspection and processing of licence for a facility with an admission service |
335,000 00 |
|
(ii) inspection and processing of licence for a facility without an admission service |
200,000 00 |
|
(iii) reinspection fees of premises, if previously failed |
*cost of travel |
|
(f) medical device: wholesale, retail and cosmetic shop— |
|
|
(i) inspection and processing |
710,000 00 |
|
(ii) reinspection fees of premises, if previously failed |
*cost of travel |
|
*Cost of travel shall be determined by agreement between the Authority and the applicant. |
|
|
4. Retention fees for premises— |
|
|
(a) manufacturing licence— |
|
|
(i) premises with oral dosage forms (solids and liquids) |
350,000 00 |
|
(ii) premises with external preparations |
260,000 00 |
|
(iii) premises with sterile preparations |
400,000 00 |
|
(iv) primary packaging only |
200,000 00 |
|
(v) secondary packaging only |
120,000 00 |
|
(b) wholesale pharmacy licence— |
|
|
(i) retention fees |
320,000 00 |
|
(ii) inspection and relocation processing |
520,000 00 |
|
(c) retail pharmacy licence— |
|
|
(i) retention fees |
160,000 00 |
|
(ii) inspection and relocation processing |
235,000 00 |
|
(d) medicine store and veterinary shop licence— |
|
|
(i) retention fees |
60,000 00 |
|
(ii) inspection and relocation processing |
160,000 00 |
|
(e) medical device: wholesale, retail and cosmetic shop— |
|
|
(i) retention fees |
320,000 00 |
|
(ii) inspection and relocation processing |
560,000 00 |
|
(f) dispensing licence— |
|
|
(i) retention for a facility with an admission service |
160,000 00 |
|
(ii) inspection and relocation processing |
235,000 00 |
|
(iii) retention for a facility without and admission service |
55,000 00 |
|
(iv) inspection and relocation processing |
155,000 00 |
|
5. Registration of medicinal products— |
|
|
(a) human, veterinary and herbal medicinal products— |
|
|
(i) human or veterinary product manufactured in Malawi |
300,000 00 |
|
(ii) human or veterinary product manufactured in Malawi (expedited processing of application) |
600,000 00 |
|
(iii) human or veterinary product manufactured outside Malawi |
US$1500 00 |
|
(iv) human or veterinary product manufactured outside Malawi (expedited processing of application) |
US$3000 00 |
|
(v) herbal product manufactured in Malawi |
80,000 00 |
|
(vi) herbal product manufactured outside Malawi |
US$1,100 00 |
|
(vii) human or veterinary product packed in Malawi but manufactured outside Malawi |
US$450 00 |
|
6. *Retention fees for medicinal products— |
|
|
(a) human or veterinary and herbal medicinal products— |
|
|
(i) human… |
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