Ministry of Health of the Slovak Republic in accordance with § 60 (1) point. (a) Act No 140/1998 Coll. on medicinal products and medical devices, amending Act No 455/1991 On 30 November 2010, the Commercial Business Act, as amended, and the amendment of the Law of the National Council of the Slovak Republic No 220/1996 Coll. on Advertising as amended (hereinafter "the Act') approved the Expert Guideline MZ SR No: OF/1511/2010, which regulates the number of packs of drug precursor products required for one treatment cycle. The Annex to the Expert Guideline sets out the number of packs of the drug precursor product required for one treatment cycle for the purpose of dispensing the medicinal product under Articles 35 (4) and 38 (7) of the Act.
This number was established according to a valid summary of product characteristics approved at the marketing authorisation and included in the marketing authorisation for the medicinal product containing the drug precursor.
Pursuant to Articles 35 (4) and 38 (7) of the Law, a person authorised to dispense medicinal products obtained without a prescription may dispense a drug containing a drug precursor only in the number of packs in which it is necessary for one treatment cycle.
The aim of the Technical Guidelines is to ensure equal treatment in all public pharmacies for the dispensing and dispensing of medicinal products containing a drug precursor which are obtained without a prescription.
Expert Guideline of the Ministry of Health of the Slovak Republic No: OF/1511/2010 of 30 November 2010 governing the number of packs of drug precursor medicinal product required for one treatment cycle
Ministry of Health of the Slovak Republic pursuant to § 60 (1) (a). (a) Act No 140/1998 Coll. on medicinal products and medical devices, amending Act No 455/1991 The following expert guidance is issued on trade (Civic Law), as amended, and on the amendment of the Law of the National Council of the Slovak Republic No 220/1996 Coll. on Advertising, as amended, (hereinafter "the Act'):
Art. 1
The number of packs of drug precursor medicinal product required for one treatment cycle for the purpose of dispensing the medicinal product pursuant to Articles 35 (4) and 38 (7) of the Act is listed in an annex to this Expert Guideline.
Art. 2
This expert guidance takes effect on the date of publication in the Journal of the Ministry of Health of the Slovak Republic.
Ivan Uhliarik, v. r.,
minister
Annex to Expert Guideline OF/1511/2010
Number of packs of the drug precursor product needed per treatment cycle
| Code ŠÚKL | Name | Appendix | Drug precursor content in the drug unit formulation | Content of the drug precursor in the package | Maximum use duration according to the SPC | Number of packs per treatment cycle | Total amount of drug precursor |
| 52368 | COMPLEX ASSPIRIN | 10 (5x2) | 30 mg | 300 | 3 days (without consulting your doctor) | 2 | 600 |
| 52369 | COMPLEX ASSPIRIN | gru por 20 (10x2) | 30 mg | 600 | 3 days (without consulting your doctor) | 1 | 600 |
| 40094 | DALERON COLD3 | tbl flm 24 | 30 mg | 720 | not specified | 1 | 720 |
| 40089 | DALERON COLD3 | tbl flm 12 | 30 mg | 360 | not specified | 2 | 720 |
| 40088 | DALERON COLD3 | tbl flm 10 | 30 mg | 300 | not specified | 2 | 600 |
| 45935 | MODAFEN | tbl flm 10 | 30 mg | 300 | 5 days | 2 | 600 |
| 7987 | MODAFEN | tbl flm 12 | 30 mg | 360 | 5 days | 2 | 720 |
| 11024 | MODAFEN | tbl flm 24 | 30 mg | 720 | 5 days | 1 | 720 |
| 87178 | NUROFENSTOPGRIP | tbl flm 12 | 30 mg | 360 | 5 days | 2 | 720 |
| 87179 | NUROFENSTOPGRIP | tbl flm 24 | 30 mg | 720 | 5 days | 1 | 720 |
| 40802 | PANADOLPLUSGRIP | tbl flm 2 (bl.) | 30 mg | 60 | 5 days | 12 | 720 |
| 40803 | PANADOLPLUSGRIP | tbl flm 5 (blist) | 30 mg | 150 | 5 days | 4 | 600 |
| 40809 | PANADOLPLUSGRIP | tbl flm 24 (blist) | 30 mg | 720 | 5 days | 1 | 720 |
| 40804 | PANADOLPLUSGRIP | tbl flm 6 (blist) | 30 mg | 180 | 5 days | 4 | 720 |
| 40805 | PANADOLPLUSGRIP | tbl flm 10 (blist) | 30 mg | 300 | 5 days | 2 | 600 |
| 40806 | PANADOLPLUSGRIP | tbl flm 12 (blist) | 30 mg | 360 | 5 days | 2 | 720 |
| 40807 | PANADOLPLUSGRIP | tbl flm 16 (blist) | 30 mg | 480 | 5 days | 1 | 480 |
| 40808 | PANADOLPLUSGRIP | tbl flm 18 (blist) | 30 mg | 540 | 5 days | 1 | 540 |
| 30228 | PARALEN PLUS | tbl flm 12 | 30 mg | 360 | 5 days | 2 | 720 |
| 40090 | PARALEN PLUS | tbi flm 10 | 30 mg | 300 | 5 days | 2 | 600 |
| 30229 | PARALEN PLUS | tbl flm 24 | 30 mg | 720 | 5 days | 1 | 720 |